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FAMOTIDINE by Bryant Ranch Prepack

Dosage form: tablet
Ingredients: FAMOTIDINE 20mg
Labeler: Bryant Ranch Prepack
NDC Code: 63629-2904

Famotidine Tablets, USP
20 mg


Drugs Facts

Active ingredient (in each tablets)

Famotidine USP 20 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.
  • if you have kidney disease, except under the advice and supervision of a 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 at any time from 10 to 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
  • store at 20°-25°C (68°-77°F)
  • keep the carton. It contains important information.
  • protect from moisture

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

Questions or comments?

Call 1-800-346-6854Manufactured by:Wockhardt Limited,Mumbai, India.Distributed by:Wockhardt USA LLC.20 Waterview Blvd.Parsippany, NJ 07054 USA.Iss.130810

Famotidine 20mg Tablet
FAMOTIDINE  
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-2904(NDC:64679-374)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 
STARCH, CORN 
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
TALC 
MAGNESIUM STEARATE 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (barrel shaped) Size9mm
FlavorImprint CodeW374
Contains    
Packaging
#Item CodePackage Description
1NDC:63629-2904-490 TABLET in 1 BOTTLE
2NDC:63629-2904-320 TABLET in 1 BOTTLE
3NDC:63629-2904-130 TABLET in 1 BOTTLE
4NDC:63629-2904-260 TABLET in 1 BOTTLE
5NDC:63629-2904-5100 TABLET in 1 BOTTLE
6NDC:63629-2904-610 TABLET in 1 BOTTLE
7NDC:63629-2904-7120 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09083708/06/2010
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(63629-2904), RELABEL(63629-2904)

Revised: 12/2017
 
Bryant Ranch Prepack

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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