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Famotidine by Teva Pharmaceuticals USA, Inc.

Dosage form: tablet, film coated
Ingredients: FAMOTIDINE 10mg
Labeler: Teva Pharmaceuticals USA, Inc.
NDC Code: 0093-2748

Famotidine
Tablets USP
10 mg
ACID REDUCER

Drug Facts

Active ingredient (in each tablet)

Famotidine, USP 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. (1-800-222-1222)

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 anytime from 15 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
  • TAMPER-EVIDENT: Do not use this product if carton has
    been opened, if blister backing appears to have been
    disturbed, or if individual blister units are broken or torn.
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture

Inactive ingredients

colloidal silicon dioxide, FD&C Red #40 aluminum lake,
FD&C Yellow #6 aluminum lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
pregelatinized starch, sodium starch glycolate, talc,
titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

Principal Display Panel, Part 1 of 2

Principal Display Panel, Part 2 of 2

Famotidine Tablets USP 10 mg Acid Reducer, Just One Per Dose, 30s Carton Text

Prevents and Relieves Heartburn Due to Acid Indigestion

NDC 0093-2748-65

Tamper-Evident

Famotidine

Tablets USP

10 mg

ACID REDUCER

30 TABLETS Just One Per Dose

TEVA

FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0093-2748
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeTEVA;2662
Contains    
Packaging
#Item CodePackage Description
1NDC:0093-2748-653 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:0093-2748-925 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:0093-2748-947 BLISTER PACK in 1 CARTON
310 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551201/08/2015
Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

 
Teva Pharmaceuticals USA, Inc.

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Medically reviewed on Sep 3, 2018

Further information

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

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