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

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 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 LABEL Item Code (Source) NDC:42507-207
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (FAMOTIDINE) 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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