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FAMOTIDINE by WOCKHARDT USA LLC.

Medically reviewed on May 10, 2018

Dosage form: tablet
Ingredients: FAMOTIDINE 10mg
Labeler: WOCKHARDT USA LLC.
NDC Code: 64679-972

Drug Facts

Active ingredient (in each tablet)                                                                        Purpose
Famotidine USP 10 mg ...............................................................................................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
  • store at 25°-30°C (77°-86°F)
  • protect from moisture
  • keep the carton and package insert. They contain important information.

Inactive ingredientshydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide.

Questions or comments?Call 1-800-346-6854

Manufactured by:
Wockhardt Limited,
Mumbai, India.

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Iss.100510



FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-972
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE ) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
TALC 
MAGNESIUM STEARATE 
HYPROMELLOSE 2910 (6 CPS) 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
FERRIC OXIDE RED  
WATER 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint CodeW;972
Contains    
Packaging
#Item CodePackage Description
1NDC:64679-972-01100 TABLET (TABLET) in 1 BOTTLE
2NDC:64679-972-0210 BLISTER PACK (BLISTER PACK) in 1 CARTON
210 TABLET (TABLET) in 1 BLISTER PACK
3NDC:64679-972-0050000 TABLET (TABLET) in 1 DRUM
4NDC:64679-972-0340000 TABLET (TABLET) in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07714603/07/2005
Labeler - WOCKHARDT USA LLC. (170508365)

 
WOCKHARDT USA LLC.

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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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