DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KROGER COMPANY]

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DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KROGER COMPANY]
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NDC 30142-213-71
Set ID bf2fcb88-418f-4d5d-85ba-ec165a53ab04
Category HUMAN OTC DRUG LABEL
Packager Kroger Company
Generic Name
Product Class
Product Number
Application Number ANDA077355
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  • Active ingredients (in each chewable tablet)

    Famotidine 10 mg

    Calcium carbonate 800 mg

    Magnesium hydroxide 165 mg

  • Purposes

    Acid reducer

    Antacid

  • Use

    relieves heartburn associated with acid indigestion and sour stomach

  • 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).

  • 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
  • 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
  • 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

  • Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredients of PEPCID COMPLETE® See back panel

    DUAL ACTION 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

    Cool Mint Flavor

    Our Pharmacists Recommend

    actual size

    50 CHEWABLE TABLETS

    dual-action-complete image
  • INGREDIENTS AND APPEARANCE
    DUAL ACTION COMPLETE 
    famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGE (PEACH WITH WHITE SPECKLES) Scoreno score
    ShapeROUNDSize18mm
    FlavorMINTImprint Code L546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-213-7150 in 1 BOTTLE; Type 0: Not a Combination Product02/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735502/03/2016
    Labeler - Kroger Company (006999528)
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