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

  • Label RSS
  • NDC Code(s): 59779-673-63, 59779-673-71, 59779-673-98
  • Packager: CVS Pharmacy
  • 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 04/14

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  • 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 320 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, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, 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 the active ingredients in Pepcid Complete®

    Dual Action

    COMPLETE

    FAMOTIDINE 10 mg/CALCIUM CARBONATE 800 mg

    MAGNESIUM HYDROXIDE 165 mg TABLETS

    Acid Reducer plus Antacid

    Just one tablet

    Relieves heartburn due to acid indigestion

    ACTUAL SIZE

    50 CHEWABLE TABLETS

    BERRY FLAVOR

    Complete Label Image 1Complete Label Image 2

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  • INGREDIENTS AND APPEARANCE
    COMPLETE 
    famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-673
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
    MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 165 mg
    CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 800 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    DEXTRATES  
    GLYCERYL MONOSTEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    ANHYDROUS LACTOSE  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POLYSORBATE 80  
    POVIDONES  
    TALC  
    Product Characteristics
    Color PINK (mottled) Score no score
    Shape ROUND (bi-layered) Size 17mm
    Flavor BERRY Imprint Code L321
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-673-63 25 in 1 BOTTLE
    2 NDC:59779-673-71 50 in 1 BOTTLE
    3 NDC:59779-673-98 75 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077355 08/05/2008
    Labeler - CVS Pharmacy (062312574)
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