DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]

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  • DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]

DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]
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NDC 56062-263-63, 56062-263-71
Set ID 913073fe-22ce-40a3-ad22-bf3027c21e99
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
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
    •
    kidney disease
  • Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Antacids and acid reducers 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. It contains important information.
    •
    store at 68-77°F (20-25°C)
    •
    protect from moisture
  • 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

  • Package/Label Principal Display Panel

    SEE NEW WARNINGS

    BERRY FLAVOR

    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

    ACTUAL SIZE

    Compare to active ingredients in Pepcid Complete®

    25 CHEWABLE TABLETS

    321-63-dual-action-complete.jpg
  • INGREDIENTS AND APPEARANCE
    DUAL ACTION COMPLETE 
    famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-263
    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)  
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK (mottled) Scoreno score
    ShapeROUND (bi-layered) Size17mm
    FlavorBERRYImprint Code L321
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-263-6325 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2018
    2NDC:56062-263-7150 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735511/06/2018
    Labeler - Publix Super Markets Inc (006922009)
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