small round tablet with imprint code J5
 

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Sodium Fluoride Chewable Tablets



Fluoride Chewable Tablets 1 mg

Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, Magnesium Stearate.

DOSAGE AND ADMINISTRATION:

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

STORAGE:

Store at a Controlled Room Temperature 20?-25?C (68?-77?F)

743634

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   172-12

Container Label

NDC 51862-172-12

Fluoride Chewable Tablets

1 mg

(From 2.2 mg of Sodium Fluoride)

Cherry Flavor       120 Tablets       Rx Only

Libertas
Pharma Inc.


FLUORIDE 
fluoride  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-172 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength CHERRY   LACTOSE   SACCHARIN   D&C RED NO. 7   MAGNESIUM STEARATE   Product Characteristics Color RED Score no score Shape ROUND Size 6mm Flavor CHERRY Imprint Code 172 Contains          Packaging # NDC Package Description Multilevel Packaging 1 51862-172-12 120 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/21/2011
Labeler - Libertas Pharma, Inc. (962128943) Revised: 05/2011Libertas Pharma, Inc.

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Sentry HC Worm X



Dosage Form: FOR ANIMAL USE ONLY
Broad Spectrum De-Wormer Chewable Tablets for Large Dogs INDICATIONS & USAGE

For Removal of Hookworms in Puppies and Dogs

Ancylostoma caninum Uncinaria stenocephala For Removal of Large Roundworms (Ascarids) in Puppies and Dogs
Toxocara canis Toxascaris leonina To Prevent Reinfection of Large Roundworms in Puppies, Adult Dogs and Lactating Bitches After Whelping
Toxocara canis ACTIVE INGREDIENT (in each chewable) Pyrantel Pamoate (113.5 mg) How is Sentry HC Worm X Supplied Net Contents:    2 Tablet Count
Net Contents:    4 Tablet Count
Net Contents:  12 Tablet Count STORAGE Store at controlled room temperature of 59-86 degrees F (15-30 degrees C). PACKAGE LABEL PRINCIPAL DISPLAY PANEL Sentry HC Worm X
Distributed by:
Sergeant's Pet Care Products, Inc., Omaha NE 68130
www.sentrypetcare.com
ANADA #200-281, Approved by FDA
Sentry HC Worm X 
pyrantel pamoate  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-402 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 113.5 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor LIVER (Pork Liver Powder) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-402-02 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 2 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-02) 2 21091-402-04 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-04) 3 21091-402-12 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200281 01/16/2008
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 manufacture Revised: 11/2010Sergeant's Pet Care Products, Inc.

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Excel Roundworm Tablets



Dosage Form: FOR ANIMAL USE ONLY
Drug Facts Active Ingredient

100mg Piperazine base as Piperazine Dihydrochloride, per each tablet.

Use

Effective against large roundworms (Toxocara cati and Toxascaris leonina)

Warnings

Do not worm a kitten under six weeks of age.

Never worm a sick cat or kitten.

Consult your veterinarian in the diagnosis, treatment and control of parasitism.

Not recommended for cats under 2 lbs. of body weight.

Not recommended for pregnant or nursing females.

Pets over 1 year old should have a recent negative heartworm blood test before de-worming.

Cautions

Although piperazine has a high degree of safety, an ocassional animal may show nausea, vomiting, or muscular tremors. Such side effects are usually associated with over dosage, therefore, the recommended dosage should be followed carefully. If symptoms occur, consult a veterinarian immediatelty.

Keep this product out of reach of children and pets to avoid unintended consumption.

Directions

Administer as follows:

Treatment should be given shortly after pet has eaten or with food. Dosage may be fed directly or added to food. For multiple pet households, feed directly to individual pet to ensure proper dosage.

Cats and kittens ( 6 weeks or older)

kittens 2-4lbs. administer 1/2 tablet, cats and kittens over 4 lbs., 1 tablet per 4 lbs. of body weight.

After initial dose on day one, do not administer again until day 10. On day 10, repeat initial dose. Then administer every 30 days to prevent reinfestation.

Other Information

Store between 20-25C (68-77F)

Inactive Ingredients

Dicalcium phosphate Dihydrate, FD C Blue #1, Isopropyl  Alcohol, magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Water, USP Purified.

Excel Roundworm De-Wormer

Effectively Removes Roundworms

For Cats and Kittens

30 Tasty

Chew Tabs


EXCEL 
roundworm de-wormer for cats and kittens  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 24730-706 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIPERAZINE (PIPERAZINE) PIPERAZINE 3 g  in 7.5 g Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE   FD&C BLUE NO. 1   ISOPROPYL ALCOHOL   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POVIDONE K30   WATER   Product Characteristics Color blue Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code NONE Contains          Packaging # NDC Package Description Multilevel Packaging 1 24730-706-08 1 BOX In 1 BOX contains a BLISTER PACK (24730-706-17) 1 24730-706-17 7.5 g In 1 BLISTER PACK This package is contained within the BOX (24730-706-08)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/17/2010
Labeler - United Pet Group (931135730) Establishment Name Address ID/FEI Operations Lloyd Inc. 791573233 manufacture Revised: 04/2010United Pet Group

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Triple Wormer



Dosage Form: FOR ANIMAL USE ONLY
TripleWormer™
(pyrantel pamoate/praziquantel)

FOR PUPPIES AND SMALL DOGS

Durvet Triple Wormer™ Flavored Chewables
Package contents: Blisters of 2 or 12 chewables

DRUG FACTS

Active Ingredients (in each chewable)

Pyrantel Pamoate (30mg) and Praziquantel (30mg)

Purpose

De-wormer for Small Dogs and Puppies Only (6.0 to 25 pounds)

Uses

For the treatment and control of

Roundworms (Toxocara canis, Toxascaris leonina) Hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) Tapeworms (Dipylidium caninum, Taenia pisiformis) Human Warning

Keep this and all medication out of the reach of children. To obtain product information, including a Material Safety Data Sheet (MSDS), call 1-800-821-5570.

When Using This Product:

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Durvet Triple Wormer™ Flavored Chewables are safe for use in puppies12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. You May Notice

Vomiting, loose stools (with or without blood) and decreased activity following treatment. If you notice these signs, contact a veterinarian.

Directions

Each flavored chewable contains 30 mg of pyrantel pamoate and 30 mg of praziquantel. The dose for each drug is 2.27 mg per pound of body weight (5 mg/kg). Please refer to the following dosing table for help finding the right dose for your dog.

Durvet Triple Wormer™ Flavored Chewables Dosing Table Dog Weight Number of Chewables 6.0 to 12.0 pounds 1 12.1 to 25 pounds 2 More than 25 pounds Use the 114 mg size You should weigh your dog to make sure you are giving the right dose. Durvet Triple Wormer™ Flavored Chewables are palatable if offered by hand. If your dog does not voluntarily eat the chewable, you can hide the chewable in a small amount of food or place it in the back of the dog's mouth for forced swallowing. Make sure that the dog eats the complete dose. Watch the dog for a few minutes after dosing to make sure the chewable is not rejected. OTHER INFORMATION Recommended De-Worming Schedule

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. De-worming schedules may vary depending on the climate where you live and the activity of your dog.

Re-treatment

Re-treatment of your dog may be necessary as determined by laboratory fecal examination and/or if your dog is living where re-infections are likely to occur. Consult your veterinarian for assistance in the diagnosis and prevention of re-infection. In case of re-infection with tapeworms (Dipylidium caninum), consult your veterinarian for advice on how to remove fleas from the dog and the environment.

Storage

Store at controlled room temperature of 59-86°F (15-30°C).

Questions? Comments?

To report a suspected adverse reaction, call 1-800-821-5570

If you have questions or comments about this product, please write: Durvet, Inc., PO Box 279, Blue Springs, MO 64013

Manufactured for:
Durvet, Inc., 100 S.E. Magellan Drive, Blue Springs, MO 64014

MADE IN USA

NADA141-261, Approved by FDA ACAV P002632-1 06/07

PRINCIPAL DISPLAY PANEL - 30 mg Tablet Carton

NDC 30798-185-61

FOR PUPPIES AND SMALL DOGS

TripleWormer™
(pyrantel pamoate/praziquantel)

2
tablets

CHEWABLE FLAVORED DOG DE-WORMER TABLETS

Broad Spectrum
De-Wormer

For Puppies & Small Dogs
6 lbs. to 25 lbs.

For the treatment and control of:

roundworms (Toxocara canis, Toxascaris leonina);

hookworms (Ancylostoma caninum, Ancylostoma
braziliense, Uncinaria stenocephala);

tapeworms (Dipylidium caninum,Taenia
pisiformis) in dogs and puppies.

Active ingredient: Each flavored chewable contains
30 mg pyrantel pamoate and 30 mg praziquantel.

KEEP OUT OF REACH OF CHILDREN

FOR USE ONLY AS DIRECTED ON PACKAGE INSERT & BACK PANEL

NET CONTENTS: 2 FLAVORED TABLETS
NADA #141-261, APPROVED BY FDA

durvet


Triple Wormer 
pyrantel pamoate and praziquantel  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 30798-185 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pyrantel pamoate (pyrantel) pyrantel pamoate 30 mg praziquantel (praziquantel) praziquantel 30 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BROWN Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 30798-185-61 2 TABLET In 1 BOX, UNIT-DOSE None 2 30798-185-71 12 TABLET In 1 BOX, UNIT-DOSE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141261 03/06/2010
Labeler - Durvet, Inc. (056387798) Registrant - Virbac AH, Inc. (131568396) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 MANUFACTURE Revised: 03/2010Durvet, Inc.

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Sentry AQ Mardel Tablet



Dosage Form: FOR ANIMAL USE ONLY
Medication for Saltwater and Freshwater Fish Indications and Usage for Sentry AQ Mardel Tablet For the treatment and control of visible parasites that  cause symptoms of gasping for air, rapid breathing, flicking, listless behavior and excess mucus production.
Treats Parasites including:  Leaches, Lice (Argulus), Flukes, Hexamita, Ick, Anchor Worms (Lernia), Protozoan/Parasites.
DIRECTIONS FOR USE It is recommended to treat infected fish in a separate isolation tank.  Remove carbon from the filter but do not discontinue filtration.  Take a disposable cup and half fill with aquarium water.  Dissolve one tablet for every 10 gallons (38 liters) of aquarium water.  Dispense the medication throughout the treatment aquarium.  One treatment should be adequate.  If parasites or symptoms are still present 24 hours after initial treatment, change 25% of the water and treat again.  Replace filter carbon 24 hours after final treatment.  If fish show signs of stress during treatment, change 50-75% of the water immediately. 
Warnings This product contains a chemical known to the State of California to cause cancer.  For aquarium use only.  Not for use on fish intended for human consumption  Do not use on paranhas, Metyniss species, scaleless fish, bottom feeders, marine sharks, lionfish, live rock, invertebrates and amphibians.  Clout may stain silicon sealant and aquarium decorations.
KEEP OUT OF REACH OF CHILDREN
STORAGE Store at room temperature.
INGREDIENTS 4-[p-(dimethylamino)-)O-phenylbenzylidene]-2, 5-cyclohexadien-1-xylidene dimethylammonium chloride; dimethyl (2,2,2-trichloro-1-hydroxyethel) phosphonate; 1,2-dimethyl-5-nitroimidazole and inert ingredients as non-toxic binders.
QUESTIONS OR COMMENTS Sentry is committed to providing high quality products.  If you have questions or comments about this product, please write:
Sentry Consumer Response
P O Box 540399
Omaha NE 68154-0399 How is Sentry AQ Mardel Tablet Supplied Sentry AQ Mardel Clout - 10 count
Sentry AQ Mardel Clout - 100 count
PACKAGE LABEL PRINCIPAL DISPLAY PANEL Sentry AQ Mardel Clout
Distributed by:
Sergeant's Pet Care Products, Inc., Omaha NE 68130
Made in USA
www.sentrypetcare.com
SENTRY AQ MARDEL CLOUT 
microcrystalline cellulose  tablet Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-301 Route of Administration EXTRACORPOREAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELLULOSE, MICROCRYSTALLINE (CELLULOSE, MICROCRYSTALLINE ) CELLULOSE, MICROCRYSTALLINE 0.29 g METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 0.19 g TRICHLORFON (TRICHLORFON) TRICHLORFON 0.0095 g MALACHITE GREEN (MALACHITE GREEN) MALACHITE GREEN 0.0038 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color blue (blue-green with dark blue specks) Score no score Shape ROUND Size 11mm Flavor Imprint Code None Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-301-10 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-301-10) 2 21091-301-00 100 TABLET In 1 BOTTLE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/10/2010
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Establishment Name Address ID/FEI Operations Sulzbach Enterprises, Inc. 616846528 manufacture Revised: 07/2010Sergeant's Pet Care Products, Inc.

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Urispas


flavoxate hydrochloride
Dosage Form: Tablets
Urispas Description

Urispas® (flavoxate HCl) tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C24H25NO4• HCl. The molecular weight is 427.94. The structural formula appears below.

Urispas® is supplied in tablets for oral administration. Each round, white, film-coated Urispas® tablet is debossed with the product name Urispas® and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, starch and talc.

Urispas - Clinical Pharmacology

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours.

Indications and Usage for Urispas

Urispas® (flavoxate HCl) is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Urispas® is not indicated for definitive treatment, but is compatible with drugs used for the treatment of urinary tract infections.

Contraindications

Urispas® (flavoxate HCl) is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Warnings

Urispas® (flavoxate HCl) should be given cautiously in patients with suspected glaucoma.

Precautions Information for Patients:

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Urispas® (flavoxate HCl) have not been performed.

Pregnancy:

Teratogenic Effects-Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urispas® is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

Overdosage

The oral LD50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD50 for flavoxate HCl in mice is 1837 mg/kg.

It is not known whether flavoxate HCl is dialyzable.

Urispas Dosage and Administration Adults and children over 12 years of age:

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

How is Urispas Supplied

Urispas® (flavoxate HCl), 100 mg, is supplied as round, white, film-coated tablets, debossed with the product name Urispas® in bottles of 100.

100 mg 100's: NDC 17314-9220-1

Store between 15° and 30°C (59° and 86°F).

Rx only

Revision Date: AUGUST 2004

Manufactured by

Cardinal Health

Winchester, Kentucky 40391

Distributed by
ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869

Printed in U.S.A.

631-10-843-2


Urispas 
flavoxate hydrochloride  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17314-9220 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength flavoxate hydrochloride (flavoxate) Active 100 MILLIGRAM  In 1 TABLET calcium phosphate Inactive   hypromellose Inactive   magnesium stearate Inactive   polyethylene glycol Inactive   starch Inactive   talc Inactive   Product Characteristics Color WHITE (white ) Score no score Shape ROUND (round) Size 10mm Flavor Imprint Code Urispas Contains          Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 17314-9220-1 100 TABLET In 1 BOTTLE None
Revised: 02/2006ORTHO-McNEIL PHARMACEUTICAL, INC. More Urispas resources Urispas Side Effects (in more detail) Urispas Dosage Urispas Use in Pregnancy & Breastfeeding Drug Images Urispas Drug Interactions Urispas Support Group 0 Reviews for Urispas - Add your own review/rating Urispas Concise Consumer Information (Cerner Multum) Urispas MedFacts Consumer Leaflet (Wolters Kluwer) Urispas Monograph (AHFS DI) Urispas Advanced Consumer (Micromedex) - Includes Dosage Information Flavoxate Professional Patient Advice (Wolters Kluwer) Compare Urispas with other medications Dysuria Overactive Bladder Urinary Incontinence
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MultiVit with Fluoride Chewable Tablets



Dosage Form: chewable tablets
Multi-Vitamin With Fluoride Chewable Tablets
Rx Only *Daily Value not established Supplement Facts Serving Size: 1 Chewable Tablet Amount Per Tablet % Daily Value Adults & children 4 years or more Vitamin A ................................. 2500 IU 50% Vitamin C ................................... 60 mg 100% Vitamin D .................................. 400 IU 100% Vitamin E .................................... 15 IU 50% Thiamin (B1) .......................... 1.05 mg 70% Riboflavin (B2) ......................... 1.2 mg 71% Niacin ..................................... 13.5 mg 68% Vitamin (B6) ........................... 1.05 mg 53% Folate ........................................ 0.3 mg 75% Vitamin B12 ............................ 4.5 mcg 75% Fluoride (as sodium fluoride) ... 1.0 mg *

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Artificial grape flavor, ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, D&C Red # 7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2.  After enamel has been laid down, fluoride deposition continues in the surface enamel.  Diffusion of fluoride from the surface inward is apparently restricted.

3.  After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNINGS

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.

If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis. ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION *1.0 ppm = 1 mg / liter **2.2 mg Sodium Fluoride contains 1mg fluoride ion. Fluoride Ion Level in Drinking Water (ppm)* AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm 4-6 years 0.50 mg / day**
(1/2 tablet) 0.25 mg / day
(1/4 tablet) None 6-16 years 1.0 mg / day
(1 tablet) 0.50 mg / day
(1/2 tablet) None HOW SUPPLIED

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for:
Boca Pharmacal, Inc.
Coral Springs, FL 33065
www.bocapharmacal.com
1-800-354-8460 Iss. 07/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Rev 13]


MULTI-VITAMIN 
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, alpha-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-815 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 1.0 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength SODIUM CITRATE   CHOLECALCIFEROL   CYANOCOBALAMIN   FD&C BLUE NO. 1   FOLIC ACID   GELATIN   STARCH, CORN   MAGNESIUM STEARATE   MANNITOL   NIACINAMIDE   POVIDONE   PYRIDOXINE   GRAPE   RIBOFLAVIN   SILICON DIOXIDE   SODIUM ASCORBATE   THIAMINE   VITAMIN A ACETATE   ALPHA-TOCOPHEROL ACETATE   D&C RED NO. 7   ASCORBIC ACID   SUCRALOSE   BUTYLATED HYDROXYTOLUENE   CITRIC ACID MONOHYDRATE   .ALPHA.-TOCOPHEROL, DL-   MALTODEXTRIN   MEDIUM-CHAIN TRIGLYCERIDES   SUCROSE   GLYCERYL MONOSTEARATE   METHYLCELLULOSE (1500 CPS)   Product Characteristics Color PURPLE Score no score Shape ROUND (Biconvex) Size 13mm Flavor GRAPE Imprint Code BP;815 Contains          Packaging # NDC Package Description Multilevel Packaging 1 64376-815-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/06/2011
Labeler - Boca Pharmacal, Inc (170266089) Registrant - Boca Pharmacal, Inc (170266089) Establishment Name Address ID/FEI Operations Cispharma, Inc 833171445 MANUFACTURE Revised: 09/2011Boca Pharmacal, Inc
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Multi Vitamin with Fluoride



Dosage Form: tablet, chewable
Unknown Title

Multi-Vitamin With Fluoride Chewable Tablets
Rx Only

*Daily Value not established Supplement Facts Serving Size: 1 Chewable Tablet Amount Per Tablet % Daily Value Adults & children 4 years or more Vitamin A .................................. 2500 IU 50% Vitamin C ..................................... 60 mg 100% Vitamin D .................................... 400 IU 100% Vitamin E ...................................... 15 IU 50% Thiamin (B1) ............................ 1.05 mg 70% Riboflavin (B2) ........................... 1.2 mg 71% Niacin ....................................... 13.5 mg 68% Vitamin (B6) ............................. 1.05 mg 53% Folate ......................................... 0.3 mg 75% Vitamin B12 .............................. 4.5 mcg 75% Fluoride (as sodium fluoride) ... 0.25 mg *

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, FD&C yellow #6 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, orange flavor, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNINGS

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.

If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis. ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION *1.0 ppm = 1 mg / liter **2.2 mg Sodium Fluoride contains 1mg fluoride ion. Fluoride Ion Level in Drinking Water (ppm)* AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm 4-6 years 0.50 mg / day**(2 tablets) 0.25 mg / day(1 tablet) None 6-16 years 1.0 mg / day(4 tablets) 0.50 mg / day(2 tablets) None HOW SUPPLIED

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for: Boca Pharmacal, Inc.
Coral Springs, FL 33065 www.bocapharmacal.com

1-800-354-8460 Iss. 08/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Rev 18]


MULTI-VITAMIN WITH FLUORIDE 
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, .alpha.-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-813 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 0.25 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength MALTODEXTRIN   CHOLECALCIFEROL   CYANOCOBALAMIN   FD&C YELLOW NO. 6   FOLIC ACID   GELATIN   MEDIUM-CHAIN TRIGLYCERIDES   MAGNESIUM STEARATE   MANNITOL   NIACINAMIDE   POVIDONE   .ALPHA.-TOCOPHEROL ACETATE   .ALPHA.-TOCOPHEROL, DL-   RIBOFLAVIN   SILICON DIOXIDE   CITRIC ACID MONOHYDRATE   THIAMINE   VITAMIN A ACETATE   ASCORBIC ACID   GLYCERYL MONOSTEARATE   BUTYLATED HYDROXYTOLUENE   SUCROSE   PYRIDOXINE   SODIUM ASCORBATE   SODIUM CITRATE   STARCH, CORN   SUCRALOSE   ORANGE   CELLULOSE, MICROCRYSTALLINE   Product Characteristics Color ORANGE Score no score Shape ROUND (Flat) Size 13mm Flavor ORANGE Imprint Code BP;813 Contains          Packaging # NDC Package Description Multilevel Packaging 1 64376-813-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/28/2011
Labeler - Boca Pharmacal, Inc (170266089) Registrant - Boca Pharmacal, Inc (170266089) Establishment Name Address ID/FEI Operations Cispharma, Inc 833171445 MANUFACTURE Revised: 01/2012Boca Pharmacal, Inc
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Allergy Relief Tablets


loratadine
Dosage Form: tablet
Drug Facts Active ingredient

loratadine 10mg

Purpose

antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Warnings Adverse Reactions Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Overdose

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only) safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only) store at 20-25°C (68-77°F) (see USP Controlled Room Temperature) Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions

call 1-800-452-0051

 

 Distributed by Target Corp.

Minneapolis, MN 55403

copyright 2009 Target Brands, Inc.

All Rights Persevered

Principal Display

Target


ALLERGY RELIEF MEDICATION 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-315 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code GG;296 Contains          Packaging # NDC Package Description Multilevel Packaging 1 11673-315-10 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-10) 2 11673-315-40 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-40) 3 11673-315-18 1 BOTTLE In 1 CARTON contains a BOTTLE 3 180 TABLET In 1 BOTTLE This package is contained within the CARTON (11673-315-18) 4 11673-315-60 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-60) 5 11673-315-30 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-30) 6 11673-315-15 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 6 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA075209 01/31/2010
Labeler - Target Brands, Inc. (006961700) Revised: 09/2010Target Brands, Inc. More Allergy Relief Tablets resources Allergy Relief Tablets Side Effects (in more detail) Allergy Relief Tablets Dosage Allergy Relief Tablets Use in Pregnancy & Breastfeeding Allergy Relief Tablets Drug Interactions 0 Reviews for Allergy Reliefs - Add your own review/rating Compare Allergy Relief Tablets with other medications Hay Fever Urticaria
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Topcare Complete Acid Reducer plus Antacid



Dosage Form: tablet, chewable
Topco Complete Acid Reducer plus Antacid Drug Facts Active ingredient (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Uses

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor Other information each tablet contains: calcium 320 mg; magnesium 65 mg Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet read the directions and warnings before use read the bottle label. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture Inactive ingredients

aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

1-888-423-0139

Principal Display Panel

Dual Action

Complete

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets

Acid Reducer plus Antacid

Just One Tablet

Relieves Heartburn Due to Acid Indigestion

Berry Flavor

Actual Size

Compare to Pepcid® Complete active ingredients

Complete Acid Reducer plus Antacid Label


TOPCARE COMPLETE 
famotidine, calcium carbonate and magnesium hydroxide  tablet, chewable Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-321 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 165 mg CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color PINK (mottled) Score no score Shape ROUND (bi-layered) Size 17mm Flavor BERRY Imprint Code L321 Contains          Packaging # NDC Package Description Multilevel Packaging 1 36800-321-63 25 TABLET In 1 BOTTLE None 2 36800-321-71 50 TABLET In 1 BOTTLE None 3 36800-321-09 65 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077355 08/05/2008
Labeler - Topco Associates LLC (006935977) Revised: 05/2009Topco Associates LLC
More Topcare Complete Acid Reducer plus Antacid resources Topcare Complete Acid Reducer plus Antacid Use in Pregnancy & BreastfeedingTopcare Complete Acid Reducer plus Antacid Drug InteractionsTopcare Complete Acid Reducer plus Antacid Support Group0 Reviews for Topcare Complete Acid Reducer plus Antacid - Add your own review/rating Compare Topcare Complete Acid Reducer plus Antacid with other medications GERD
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Cetirizine Drug Facts



Dosage Form: tablet, chewable
Drug Facts Active ingredient

(in each chewable tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings

Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions may be taken with or without water adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Store between 20 to 25 C (68 to 77 F) Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor

 

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.02/2008

Principal Display Panel

 

NDC 0781-5284-64

Children's

Cetirizine HCl Chewable Tablets

10 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose

6 yrs. and older 10 mg each


CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride  tablet, chewable Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5284 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM   BENZYL ALCOHOL   BETADEX   COLLOIDAL SILICON DIOXIDE   ALPHA-TOCOPHEROL, DL-   FERRIC OXIDE RED   FERRIC OXIDE YELLOW   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   MALTODEXTRIN   CELLULOSE, MICROCRYSTALLINE   PROPYLENE GLYCOL   TALC   Product Characteristics Color YELLOW (peach, mottled) Score no score Shape ROUND Size 9mm Flavor Imprint Code SZ;106 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0781-5284-64 30 TABLET In 1 BOX, UNIT-DOSE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078692 02/14/2008
Labeler - Sandoz Inc (110342024) Revised: 09/2009Sandoz Inc
More Cetirizine Drug Facts resources Cetirizine Drug Facts Side Effects (in more detail) Cetirizine Drug Facts Dosage Cetirizine Drug Facts Use in Pregnancy & Breastfeeding Drug Images Cetirizine Drug Facts Drug Interactions Cetirizine Drug Facts Support Group 73 Reviews for Cetirizine Drug Facts - Add your own review/rating Compare Cetirizine Drug Facts with other medications Hay Fever Urticaria
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Pro-Banthine


propantheline bromide
Dosage Form: Tablets
Pro-Banthine Description

Pro-Banthine®(propantheline bromide) oral tablets contain 15 mg or 7.5 mg of the anticholinergic propantheline bromide, (2-hydroxyethyl) diisopropylmethylammonium bromide xanthene-9-carboxylate.

The structural formula of propantheline bromide is:

Propantheline bromide is very soluble in water, alcohol, and chloroform, but it is practically insoluble in ether and in benzene. Its molecular weight is 448.40.

Inactive Ingredients: include calcium carbonate, castor oil, corn starch, lactose anhydrous, light mineral oil, magnesium carbonate, magnesium stearate, saccharin sodium, sucrose, talc, titanium dioxide, and waxes. The 15-mg tablet also contains cosmetic ochre and cosmetic red as coloring agents.

Pro-Banthine - Clinical Pharmacology

Propantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the post-ganglionic nerve endings of the parasympathetic nervous system.

Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive compounds xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. After a single 30-mg oral dose given as two 15-mg tablets, the mean peak plasma concentration of propantheline was 21 ng/mL at 1 hour in 6 healthy subjects.

The plasma elimination half-life of propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of propantheline is about 3% after oral tablet administration.

Indications and Usage for Pro-Banthine

Pro-Banthine® (propantheline bromide) tablets are as effective as adjunctive therapy in the treatment of peptic ulcer.

Contraindications

Propantheline bromide is contraindicated in patients with:

Glaucoma, since mydriasis is to be avoided. Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.) Obstructive uropathy (e.g., bladder-neck obstruction due to prostatic hypertrophy). Intestinal atony of elderly or debilitated patients. Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis. Unstable cardiovascular adjustment in acute hemorrhage. Myasthenia gravis. Warnings

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Pro-Banthine®.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with propantheline bromide would be inappropriate and possibly harmful.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).

Propantheline bromide may cause increased heart rate and, therefore, should be used with caution in patients with heart disease.

Precautions General

Propantheline bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, or hiatal hernia associated with reflux esophagitis, since anticholinergics may aggravate this condition.

In patients with ulcerative colitis, large doses of propantheline bromide may suppress intestinal motility to the point of producing paralytic ileus and, for this reason, may precipitate or aggravate toxic megacolon, a serious complication of the disease.

Information for patients

Propantheline bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work, while taking this drug product.

Drug Interactions

Anticholinergics may delay absorption of other medication given concomitantly.

Excessive cholinergic blockade may occur if propantheline bromide is given concomitantly with belladonna alkaloids, synthetic or semisynthetic anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine), antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Propantheline bromide may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Concurrent use of propantheline bromide with slow-dissolving tablets of digoxin may cause increased serum digoxin levels. This interaction can be avoided by using only those digoxin tablets that rapidly dissolve by USP standards.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term fertility, carcinogenicity, or mutagenicity studies have been done with propantheline bromide.

Pregnancy Pregnancy Category C

Animal reproduction studies have not been conducted with propantheline bromide. It is also not known whether propantheline bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline bromide should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations.

Overdosage

The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) immediate induction of emesis or lavage of the stomach, (2) injection of physostigmine 0.5 to 2 mg intravenously, repeated as necessary up to a total of 5 mg, and (3) monitoring of vital signs and managing as necessary.

Fever may be treated symptomatically (cooling blanket or alcohol sponging). Excitement of a degree which demands attention may be managed with thiopental sodium 2% solution given slowly intravenously, or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, mechanical respiration should be instituted and maintained until effective respiratory action returns.

The oral LD50 of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.

Pro-Banthine Dosage and Administration

The usual initial adult dosage of Pro-Banthine®tablets is 15 mg taken 30 minutes before each meal (3 times daily), and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient's individual response and tolerance. The administration of one 7.5-mg tablet 30 minutes before each meal (3 times daily) is convenient for patients with mild manifestations, for geriatric patients, and for those of small stature.

How is Pro-Banthine Supplied

Pro-Banthine®15-mg tablets are round, peach-colored, sugar-coated, with RPC imprinted on one side and 074 on the other side. Bottles of 100 (NDC 54092-074-01).

Pro-Banthine® 7.5-mg tablets are round, white, sugar-coated, with RPC imprinted on one side and 073 on the other side. Bottles of 100 (NDC 54092-073-01).

Store below 25°C (77°F).

Rev. 2/00 073 0117 004


PRO-BANTHINE 
propantheline bromide  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-074 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength propantheline bromide (propantheline) Active 15 MILLIGRAM  In 1 TABLET calcium carbonate Inactive   castor oil Inactive   corn starch Inactive   lactose anhydrous Inactive   light mineral oil Inactive   magnesium carbonate Inactive   magnesium stearate Inactive   saccharin sodium Inactive   sucrose Inactive   talc Inactive   titanium dioxide Inactive   waxes Inactive   cosmetic ochre Inactive   cosmetic red Inactive   Product Characteristics Color PINK (PEACH) Score no score Shape ROUND Size 6mm Flavor Imprint Code RPC;074 Contains          Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 54092-074-01 100 TABLET In 1 BOTTLE None
PRO-BANTHINE 
propantheline bromide  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-073 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength propantheline bromide (propantheline) Active 7.5 MILLIGRAM  In 1 TABLET calcium carbonate Inactive   castor oil Inactive   corn starch Inactive   lactose anhydrous Inactive   light mineral oil Inactive   magnesium carbonate Inactive   magnesium stearate Inactive   saccharin sodium Inactive   sucrose Inactive   talc Inactive   titanium dioxide Inactive   waxes Inactive   Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code RPC;073 Contains          Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 54092-073-01 100 TABLET In 1 BOTTLE None
Revised: 03/2007Shire US Manufacturing Inc More Pro-Banthine resources Pro-Banthine Side Effects (in more detail)Pro-Banthine DosagePro-Banthine Use in Pregnancy & BreastfeedingPro-Banthine Drug InteractionsPro-Banthine Support Group0 Reviews for Pro-Banthine - Add your own review/rating Pro-Banthine MedFacts Consumer Leaflet (Wolters Kluwer) Pro-Banthine Concise Consumer Information (Cerner Multum) Propantheline Bromide Monograph (AHFS DI) Compare Pro-Banthine with other medications Peptic Ulcer
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Super Dent Topical Anesthetic Gel


benzocaine
Dosage Form: gel
Super Dent Topical Anesthetic Gel 20% Benzocaine DIRECTIONS FOR USE

Gel – 1oz/30mL
REF 14-31021 Cherry
REF 14-31022 Mint
REF 14-31023 Banana
REF 14-31024 Pina Colada
REF 14-31025 Bubble-Num
REF 14-31026 Strawberry
REF 14-31027 Razzberry

For dental use only.
USA: Rx only.

1. DESCRIPTION

Flavored 20% benzocaine gel for topical mucosal anesthesia.

2. INDICATIONS

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra-oral radiographs.

3. CONTRAINDICATIONS

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

4. WARNINGS

Keep out of reach of children. For professional dental use only.

5. PRECAUTIONS

Super Dent 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

6. DOSAGE AND ADMINISTRATION Each gram of Super Dent 20% benzocaine gel contains between 180-220mg benzocaine in a flavored base. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle. For topical tissue anesthesia during scaling procedures, dispense a small amount of Topex gel into a dappen dish, then coat the scaler with the product prior to use. Tightly re-cap the jar after each use. 7. STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

Darby Dental Supply LLC
Jericho, NY 11753

Made in the USA
Form #0030502DF (R 2/22/10)

PRINCIPAL DISPLAY PANEL - 30 g Label (Cherry)

super dent®

20% Benzocaine Gel

Cherry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1737
NDC 6646720021

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Mint)

super dent®

20% Benzocaine Gel

Mint Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1738
NDC 6646720031

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Banana)

super dent®

20% Benzocaine Gel

Banana Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1743
NDC 6646720051

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Bubble Gum)

super dent®

20% Benzocaine Gel

Bubble Gum Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1736
NDC 6646720011

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Strawberry)

super dent®

20% Benzocaine Gel

Strawberry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1744
NDC 6646720061

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Raspberry)

super dent®

20% Benzocaine Gel

Raspberry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1734
NDC 6646720001

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Pi?a Colada)

super dent®

20% Benzocaine Gel

Pi?a Colada Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1739
NDC 6646720041

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753


SUPERDENT  CHERRY
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2002 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color RED Score      Shape Size Flavor CHERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2002-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  MINT
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2003 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color GREEN Score      Shape Size Flavor MINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2003-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  BANANA
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2005 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color YELLOW Score      Shape Size Flavor BANANA Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2005-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  BUBBLE GUM
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2001 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color PINK Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2001-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  STRAWBERRY
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2006 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color RED Score      Shape Size Flavor STRAWBERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2006-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  RASPBERRY
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2000 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color RED Score      Shape Size Flavor RASPBERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2000-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  PINA COLADA
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2004 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2004-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
Labeler - Darby Dental Supply LLC (825137818) Registrant - DSHealthcare (056296981) Establishment Name Address ID/FEI Operations DENTSPLY Caulk 083235549 MANUFACTURE Revised: 08/2010Darby Dental Supply LLC
More Super Dent Topical Anesthetic Gel resources Super Dent Topical Anesthetic Gel Side Effects (in more detail) Super Dent Topical Anesthetic Gel Use in Pregnancy & Breastfeeding 0 Reviews for Super Dent Topical Anesthetic - Add your own review/rating Compare Super Dent Topical Anesthetic Gel with other medications Anal Itching Anesthesia Aphthous Ulcer Burns, External Cold Sores Hemorrhoids Oral and Dental Conditions Pain Pruritus Sunburn Tonsillitis/Pharyngitis
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Acid Controller Original Strength


famotidine
Dosage Form: tablet
Walgreen Co. Acid Controller Drug Facts Active ingredient (in each tablet)

Famotidine 10 mg

Purpose

Acid reducer

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor Other information read the directions and warnings before use keep the carton. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture and light Inactive ingredients

carnauba wax, hypromellose, iron oxides, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Original Strength Pepcid® AC active ingredient

Original Strength

Acid Controller

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Tablets

Acid Controller Carton


ACID CONTROLLER  ORIGINAL STRENGTH
famotidine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0363-0141 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code L141 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0363-0141-65 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0363-0141-65) 2 0363-0141-75 1 BOTTLE In 1 CARTON contains a BOTTLE 2 90 TABLET In 1 BOTTLE This package is contained within the CARTON (0363-0141-75)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075400 08/28/2009
Labeler - Walgreen Company (008965063) Revised: 06/2009Walgreen Company
More Acid Controller Original Strength resources Acid Controller Original Strength Side Effects (in more detail) Acid Controller Original Strength Dosage Acid Controller Original Strength Use in Pregnancy & Breastfeeding Acid Controller Original Strength Drug Interactions 0 Reviews for Acid Controller Original Strength - Add your own review/rating Compare Acid Controller Original Strength with other medications Allergic Urticaria Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome
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Zirtek Allergy


Zirtek ALLERGY

Cetirizine hydrochloride

ONE-A-DAY

What You Should Know About Your Tablets

Please read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy. For further information or advice ask your doctor or pharmacist.

What Is In Zirtek Allergy

Each tablet contains 10 mg of cetirizine hydrochloride together with microcrystalline cellulose (E460), lactose, colloidal anhydrous silica and magnesium stearate (E572). The film coating contains hydroxypropylmethyl cellulose (E464), titanium dioxide (E171) and polyethylene glycol.

The tablets are small white oblong film-coated tablets, each scored and bearing the code Y/Y. Your medicine is supplied in blister packs of 21 and 30 tablets.

Your medicine belongs to the antihistamine group of drugs.

Product licence number:

PL 00039/0542

This medicine is manufactured and licenced by: UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE When Is Zirtek Allergy Used

This medicine treats people suffering from hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).#

Antihistamines like Zirtek Allergy relieve the unpleasant symptoms and discomfort associated with the above conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

Before Taking Zirtek Allergy

If you are pregnant or if your doctor has told you that you have kidney problems, you should consult your doctor before taking these tablets. You should not take this medicine if you are breastfeeding or if you have ever had an allergic reaction to any of its constituents (see ‘What is in Zirtek Allergy?).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

As with all antihistamines, you should avoid excessive alcohol consumption when taking your tablets.

If you have ever had a reaction to an antihistamine in the past consult your doctor or pharmacist before taking these tablets.

How To Take Your Tablets

Adults and children 6 years and over should take one tablet daily. Children aged 6 – 12 years may either take half a tablet twice daily or one tablet daily.

Each dose should be taken with water.

REMEMBER... If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

If you accidentally take a larger dose than recommended consult your doctor immediately.

You may feel drowsy or dizzy, taking half your dose twice a day may reduce this. Zirtek Allergy tablets are not for use in children under 6 years of age.

If symptoms persist consult your doctor.

After Taking Zirtek Allergy Tablets

These tablets do not cause side-effects in most people. However, as with all medicines, some people can react differently. If you:

have frequent headaches have an upset stomach become agitated have diarrhoea get a dry mouth feel weak and/or unwell experience unusual touch sensation experience fatigue, dizziness or drowsiness experience itchiness and skin rash

Stop taking the tablets and tell your doctor.

Other rare side effects have been reported such as bleeding and bruising easily, rapid heart beat, difficulty focussing, blurred vision, swelling, allergic reaction/shock, changes in liver function, fits, confusion, depression, aggression, weight increase, unusual limb movements, experience a bad taste in the mouth, fainting, hallucination, insomnia, bed wetting, pain and/or difficulty passing water, red and/or blotchy skin rash.

If you notice anything unusual or have these or any other unexpected effects stop taking the tablets and tell you doctor. These tablets do not normally cause drowsiness. However, individuals can react differently to treatment. If you are affected you should not drive or operate machinery, but should persist with the tablets as any drowsiness doesn’t usually last very long.

Storing Your Tablets.

Keep your tablets out of reach and sight of children.

Do not use after the expiry date shown under EXP on the end panel of the carton.

LEGAL STATUS: P.

Date of preparation of this leaflet: October 2005

UCB 2004 – UCB logo


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Loratadine Drug Facts


Dosage Form: tablet
Drug Facts Active Ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose itchy, watery eyes sneezing itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease.Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only). Safety sealed: do not use if open or torn (for blister package only). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1-800-525-8747

05-2010M

Sandoz Inc.

Princeton, NJ 08540

mg Label

NDC 0781-5077-01 Non-Drowsy*

LORAtadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

100 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.


mg Blister Pack

NDC 0781-5077-64

LORAtadine Tablets, USP 10 mg

10-2009M


mg Blister Pack Carton

NDC 0781-5077-64

Non-Drowsy*

LORAtadine

Tablets, USP

10 mg Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose


LORATADINE 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5077 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code GG296 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0781-5077-76 12 CARTON In 1 CARTON contains a CARTON (0781-5077-64) 1 0781-5077-64 1 BLISTER PACK In 1 CARTON This package is contained within the CARTON (0781-5077-76) and contains a BLISTER PACK 1 30 TABLET In 1 BLISTER PACK This package is contained within a CARTON (0781-5077-64) and a CARTON (0781-5077-76) 2 0781-5077-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 01/21/2003
Labeler - Sandoz Inc (110342024) Establishment Name Address ID/FEI Operations Sandoz Inc 110342024 MANUFACTURE Establishment Name Address ID/FEI Operations Thermo-Pak, Inc 161049044 PACK, LABEL Revised: 06/2010Sandoz Inc
More Loratadine Drug Facts resources Loratadine Drug Facts Side Effects (in more detail)Loratadine Drug Facts DosageLoratadine Drug Facts Use in Pregnancy & BreastfeedingDrug ImagesLoratadine Drug Facts Drug InteractionsLoratadine Drug Facts Support Group21 Reviews for Loratadine Drug Facts - Add your own review/rating Compare Loratadine Drug Facts with other medications Hay FeverUrticaria
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Toxi Sorb Bolus



Dosage Form: FOR ANIMAL USE ONLY
TOXI-SORB BOLUS INDICATIONS

INDICATIONS: For use as an aid in relief of simple non-infectious diarrhea in horses and cattle.

DOSAGE AND ADMINISTRATION: Administer orally.Give two (2) boluses to adult cattle and horses. Give one (1) bolus to calves and foals.

Repeat treatment at 4 to 6 hour intervals as needed. Discontinue use of product  after 3 days. If symptoms persist after using this preparation for 3 days, consult a veterinarian.

T-7667-02              Rev. 12-09

COMPOSITION

COMPOSITION: Each bolus contains: Activated Attapulgite 20%, Carob Flour, Pectin and Magnesium Trisilicate, in a sugar and starch base.

Store at room temperature between 15o and 30oC (59o-86oF).

TAKE TIME OBSERVE LABEL DIRECTIONS

LOT NO.:                             EXP. DATE:


TOXI-SORB BOLUS 
activated attapulgite  tablet Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58005-667 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATTAPULGITE (ATTAPULGITE) ATTAPULGITE 3.7  g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color gray (Light gray to brownish) Score 2 pieces Shape OVAL (Oblong) Size 5mm Flavor Imprint Code 2 Contains          Packaging # NDC Package Description Multilevel Packaging 1 58005-667-02 50 BOLUS In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/01/1992
Labeler - Sparhawk Laboratories, Inc. (958829558) Revised: 01/2010Sparhawk Laboratories, Inc.

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Sunmark Heartburn Relief Drug Facts


Generic Name: cimetidine
Dosage Form: tablet
McKesson Heartburn Relief Drug Facts Active ingredient (in each tablet)

Cimetidine 200 mg

Purpose

Acid reducer

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages Warnings

Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Ask a doctor or pharmacist before use if you are taking theophylline (oral asthma medicine) warfarin (blood thinning medicine) phenytoin (seizure medicine)

If you are not sure you are taking one of these medicines, talk to your doctor or pharmacist.

Stop use and ask a doctor if your heartburn continues or worsens stomach pain continues you need to take this product for more than 14 days If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn do not take more than 2 tablets in 24 hours children under 12 years: ask a doctor Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tagamet HB 200® active ingredient

Heartburn Relief

Cimetidine Tablets USP, 200 mg

Acid Reducer

Just One Tablet Relieves and Prevents Heartburn and Acid Indigestion

Take Any Time you need it:

Before Meal

During Meal

After Meal

One Tablet Dose

Actual Size

(# Doses) {Replace "#" with number of tablets in package}

Heartburn Relief Carton


SUNMARK HEARTBURN RELIEF  ACID REDUCER
cimetidine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49348-246 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CIMETIDINE (CIMETIDINE) CIMETIDINE 200 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code L022 Contains          Packaging # NDC Package Description Multilevel Packaging 1 49348-246-44 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (49348-246-44)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075285 09/19/2003
Labeler - McKesson (177667227) Revised: 07/2009McKesson
More Sunmark Heartburn Relief Drug Facts resources Sunmark Heartburn Relief Drug Facts Side Effects (in more detail) Sunmark Heartburn Relief Drug Facts Use in Pregnancy & Breastfeeding Drug Images Sunmark Heartburn Relief Drug Facts Drug Interactions Sunmark Heartburn Relief Drug Facts Support Group 3 Reviews for Sunmark Heartburn Relief Drug Facts - Add your own review/rating Compare Sunmark Heartburn Relief Drug Facts with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Human Papilloma Virus Indigestion Lung Cancer Obesity Stomach Ulcer Stress Ulcer Prophylaxis Upper GI Hemorrhage Zollinger-Ellison Syndrome
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Kids Choice



Dosage Form: gel, dentifrice
ACTIVE INGREDIENT

Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose, Xylitol

USE

Aids in the prevention of dental decay.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.
Children 6-11 Years:  See directions above.  Adult supervision required.
Children Under 6: Consult a Dentist or Physician.

OTHER INFORMATION

This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

QUESTIONS ? COMMENTS ?

Questions?? Comments??
Call 1-479-787-5168 M-F 9am to 5pm CST

Warnings

If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

PACKAGE LABEL

Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel
Manufactured by Massco Dental







Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-005 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .45103 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-005-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-006 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CREME DE MENTHE (HINT OF MINT) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-006-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-007 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor LIME (LIMEAIDE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-007-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-008 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-008-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-009 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-009-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-015 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor COTTON CANDY (COTTON CANDY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-015-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
More Kids Choice resources Kids Choice Use in Pregnancy & Breastfeeding Kids Choice Support Group 3 Reviews for Kids Choice - Add your own review/rating Compare Kids Choice with other medications Prevention of Dental Caries
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Parafon DSC



Dosage Form: tablet
Parafon DSC (chlorzoxazone) Parafon DSC Description

Each caplet (round shaped tablet) contains:

Chlorzoxazone                    500 mg

Inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, docusate Sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium benzoate, D&C yellow No. 10 alum. Lake, FD&C blue no. 1 alum. Lake HT

Parafon DSC - Clinical Pharmacology

Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.

Indications and Usage for Parafon DSC

Chlorzoxazone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

Contraindications

Chlorzoxazone tablets are contraindicated in patients with known intolerance to the drug.

Warnings

Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g. AST, ALT, alkaline phosphatase and bilirubin).

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Usage in Pregnancy

The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.

Precautions

Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.

If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

Adverse Reactions

Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or overstimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.

Overdosage Symptoms

Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment

Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.

Parafon DSC Dosage and Administration Usual Adult Dosage

One caplet three or four times daily. If adequate response is not obtained with this dose, it may be increased to 1 ? caplets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

How is Parafon DSC Supplied

Chlorzoxazone tablets 500 mg Tablets, (round shaped tablet, light green, imprinted "555/585" and "Barr" scored).

NDC 68387-375-90, bottles of 90
NDC 68387-375-30, bottles of 30

Dispense in tight container as defined in the USP/NF.

Store at controlled room temperature (15°–30°C, 59°–86°F).

Manufactured for:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, Ms 39232

R4

Package Label - Principal Display Panel – 90-count Bottle, 500 mg Tablets

NDC 68387-375-90

Rx Only


Parafon DSC 
chlorzoxazone  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68387-375 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorzoxazone (Chlorzoxazone) Chlorzoxazone 500 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   DOCUSATE SODIUM   ANHYDROUS LACTOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM BENZOATE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   Product Characteristics Color GREEN (light green) Score 2 pieces Shape ROUND Size 17mm Flavor Imprint Code 555;585;Barr Contains          Packaging # NDC Package Description Multilevel Packaging 1 68387-375-90 90 TABLET In 1 BOTTLE None 2 68387-375-30 30 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089895 06/20/2004
Labeler - Keltman Pharmaceuticals Inc. (362861077) Establishment Name Address ID/FEI Operations Barr Laboratories, Inc. 824749340 MANUFACTURE Revised: 02/2010Keltman Pharmaceuticals Inc. More Parafon DSC resources Parafon DSC Side Effects (in more detail) Parafon DSC Use in Pregnancy & Breastfeeding Drug Images Parafon DSC Drug Interactions Parafon DSC Support Group 10 Reviews for Parafon DSC - Add your own review/rating Compare Parafon DSC with other medications Muscle Spasm
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