FAMOTIDINE ORIGINAL STRENGTH- famotidine tablet 
EQUATE (Walmart Stores, Inc.)

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Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 mg

Purpose

Acid reducer

Uses

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

Other information

Inactive ingredients

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

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Pepcid® AC® Active Ingredient*

Original Strength

Famotidine Tablets, 10 mg

Acid Reducer

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Tips for Managing Heartburn

Distributed by: Wal-Mart Stores, Inc.

Bentonville, AR 72716 ©Wal-mart Stores, Inc.

Product of India

*This product is not manufactured or distributed by © McNeil Consumer Pharmaceuticals Co., owner of the registered trademark Pepcid® AC®.

Product label

Equate

Famotidine Tablets 10 mg

FAMOTIDINE  ORIGINAL STRENGTH
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-128
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code W;972
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49035-128-90 1 in 1 BOX
1 90 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077146 12/18/2012
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2013
Document Id: 0becc489-941b-4e34-bbd0-338dec9ab0e5
Set id: c7c0db88-6287-458a-abd1-c0ebf81f2337
Version: 3
Effective Time: 20131107
 
EQUATE (Walmart Stores, Inc.)