FAMOTIDINE- famotidine tablet, film coated 
Teva Pharmaceuticals USA, Inc.

----------

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

Famotidine Tablets USP 10 mg Acid Reducer, Just One Per Dose, 30s Carton, Part 1 of 2

Principal Display Panel, Part 2 of 2

Famotidine Tablets USP 10 mg Acid Reducer, Just One Per Dose, 30s Carton, 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code TEVA;2662
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0093-2748-653 in 1 CARTON01/08/201511/26/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0093-2748-925 in 1 CARTON01/08/201511/26/2021
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0093-2748-947 in 1 CARTON01/08/201511/26/2021
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551201/08/201511/26/2021
Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2021
Document Id: fdbd1f73-5aa9-46f6-ace8-2742dc8c490e
Set id: 2a8cc600-4995-4279-b169-206d7ef8a93f
Version: 9
Effective Time: 20211116
 
Teva Pharmaceuticals USA, Inc.