Your browser does not support JavaScript! FAMOTIDINE ORIGINAL STRENGTH (FAMOTIDINE) TABLET [EQUATE (WALMART STORES, INC.)]
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RxNorm Names

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


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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.

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 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
  • store at 25°-30°C (77°-86°F)
  • protect from moisture

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

  • Just one tablet prevents and relieves heartburn due to acid indigestion

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

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-128
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code W;972
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-128-901 in 1 BOX
190 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07714612/18/2012
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2013
 
EQUATE (Walmart Stores, Inc.)

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