Label: FAMOTIDINE- famotidine tablet, film coated 

  • 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 01/13

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

    • with other acid reducers
    • 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.

    Ask a doctor before use if you have

    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain
    • 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

    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).

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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 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

    • store at 20° to 25°C (68° to 77°F)
    • protect from moisture
    • read the directions and warnings before use
    • keep the carton. It contains important information.
    • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
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  • INACTIVE INGREDIENTS

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

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  • QUESTIONS?

    Call 1-800-406-7984

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  • PATIENT INFORMATION

    • 1 tablet relieves heartburn due to acid indigestion
    • Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

    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
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  • PRINCIPAL DISPLAY PANEL

    fred's®

    Original Strength

    Acid Controller

    Famotidine Tablets USP, 10 mg

    Acid Reducer

    Just One Tablet

    Prevents & Relieves Heartburn Due to Acid Indigestion

    30 TABLETS

    Compare To Original Strength Pepcid®AC

    DISTRIBUTED BY: fred's, Inc.

    5092839/R0112

    This is the 30 count blister carton label for Fred's Famotidine tablets USP, 10 mg.
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  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-035
    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
    COLLOIDAL SILICON DIOXIDE  
    HYDROXYPROPYL CELLULOSE  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    STARCH, PREGELATINIZED CORN  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color pink Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 035
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-035-31 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090283 06/25/2010
    Labeler - Fred's Inc. (005866116)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(55315-035)
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