Label: FAMOTIDINE ORIGINAL STRENGTH- famotidine tablet

  • NDC Code(s): 49035-128-90
  • Packager: EQUATE (Walmart Stores, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Famotidine USP 10 mg

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  • Purpose

    Acid reducer

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  • 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
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  • 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.

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  • 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
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  • Other information

    • read the directions and warnings before use
    • store at 25°-30°C (77°-86°F)
    • protect from moisture
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  • Inactive ingredients

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

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  • Questions or comments?

    Call 1-888-287-1915

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  • 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®.

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  • Product label

    Equate

    Famotidine Tablets 10 mg

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  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE  ORIGINAL STRENGTH
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-128
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    STARCH, CORN  
    TALC  
    TITANIUM DIOXIDE  
    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)
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