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

  • NDC Code(s): 56062-263-63, 56062-263-71
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 6, 2018

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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  • Purposes

    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

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  • 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
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  • 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
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  • Ask a doctor or pharmacist before use if you are

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

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  • Stop use and ask a doctor if

    your heartburn continues or worsens
    you need to take this product for more than 14 days
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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 80 mg
    Phenylketonurics: Contains Phenylalanine 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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  • Package/Label Principal Display Panel

    BERRY FLAVOR

    dual action complete

    FAMOTIDINE 10mg/CALCIUM CARBONATE 800 mg/MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE)

    ACID REDUCER + ANTACID

    Just one tablet relieves heartburn due to acid indigestion

    ACTUAL SIZE

    Compare to active ingredients in Pepcid Complete®

    25 CHEWABLE TABLETS

    321-63-dual-action-complete.jpg
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  • INGREDIENTS AND APPEARANCE
    DUAL ACTION COMPLETE 
    famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-263
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    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:56062-263-63 25 in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2018
    2 NDC:56062-263-71 50 in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077355 11/06/2018
    Labeler - Publix Super Markets Inc (006922009)
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