Label: ACID REDUCER ORIGINAL STRENGTH- famotidine tablet, coated

  • NDC Code(s): 42507-207-65, 42507-207-72
  • Packager: HyVee Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 06/09

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

  • Active ingredient (in each tablet)

    Famotidine 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 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
    • keep the carton and package insert. They contain important information.
    • store at 20°-25°C (68°-77°F)
    • protect from moisture and light
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  • Inactive ingredients

    colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, indigo carmine aluminum lake FD&C blue no. 2, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, pregelatinized corn starch, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Original Strength Pepcid® AC active ingredient

    Original Strength

    Famotidine Tablets, 10 mg

    Acid Reducer

    Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

    Actual Size

    Acid Reducer Carton

    Acid Reducer Carton

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  • INGREDIENTS AND APPEARANCE
    ACID REDUCER  ORIGINAL STRENGTH
    famotidine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-207
    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
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 93;968
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-207-72 1 in 1 CARTON
    1 60 in 1 BOTTLE
    2 NDC:42507-207-65 3 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075312 09/24/2001
    Labeler - HyVee Inc (006925671)
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