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FAMOTIDINE by Bryant Ranch Prepack

Medically reviewed on Dec 3, 2017

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)

 
Bryant Ranch Prepack

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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