Label: ACID REDUCER COMPLETE- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

  • NDC Code(s): 37012-009-71
  • Packager: Shopko Stores Operating Co., LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 12, 2016

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

  • Active ingredients (in each chewable tablet)

    Famotidine 10 mg

    Calcium carbonate 800 mg

    Magnesium hydroxide 165 mg

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  • Purpose

    Acid reducer

    Antacid

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  • Use

    relieves heartburn associated with acid indigestion and sour stomach

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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

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    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:
    do not swallow tablet whole: chew completely
    to relieve symptoms, chew 1 tablet before swallowing
    do not use more than 2 chewable tablets in 24 hours
    children under 12 years: ask a doctor
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  • Other information

    each tablet contains: calcium 330 mg; magnesium 70 mg
    Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet
    read the directions and warnings before use
    read the bottle label. It contains important information.
    store at 20-25˚C (68-77˚F)
    protect from moisture
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  • Inactive ingredients

    anhydrous lactose, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Pepcid Complete® active ingredients

    Dual Action

    Acid Reducer Complete

    Famotidine 10 mg/Calcium Carbonate 800 mg

    Magnesium Hydroxide 165 mg Tablets (Chewable)

    Acid Reducer + Antacid

    Just One Tablet! Relieves Heartburn Due to Acid Indigestion

    50 Chewable Tablets

    Mint Flavor

    Actual Size

    Shopko Acid Reducer Complete Image 1
    Shopko Acid Reducer Complete Image 2
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  • INGREDIENTS AND APPEARANCE
    ACID REDUCER COMPLETE 
    famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASPARTAME (UNII: Z0H242BBR1)  
    DEXTRATES (UNII: G263MI44RU)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color ORANGE (PEACH WITH WHITE SPECKLES) Score no score
    Shape ROUND Size 18mm
    Flavor MINT Imprint Code L546
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37012-009-71 50 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077355 01/12/2016
    Labeler - Shopko Stores Operating Co., LLC (023252638)
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