Label: FAMOTIDINE- famotidine tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • 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 at any time 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
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  • 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
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  • 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

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  • Questions?

    call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

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  • PRINCIPAL DISPLAY PANEL

    Famotidine 10mg Tablet

    Label
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  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4593(NDC:0172-2662)
    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
    SILICON DIOXIDE  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE (PEACH) Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code 10;2662
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-4593-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075512 02/18/2010
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-4593), RELABEL(63629-4593)
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