FAMOTIDINE description, usages, side effects, indications, overdosage, supplying and lots more!

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FAMOTIDINE

Wockhardt USA LLC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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, Keep out of reach of children.

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

FAMOTIDINE 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 ingredients

Questions or comments?

1-800-346-6854

Manufactured by:



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FAMOTIDINE



FAMOTIDINE

FAMOTIDINE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64679-972
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
white (white) 8 mm W;972 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64679-972-01 100 in 1 BOTTLE
2 10 in 1 BLISTER PACK
3 NDC:64679-972-00 50000 in 1 DRUM
4 NDC:64679-972-03 40000 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077146 2005-03-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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