Label: MINT ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 13, 2019

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG

  • PURPOSE

    ANTACID

  • INDICATIONS & USAGE

    Uses:

    for the relief of:

    •heartburn • sour stomach • acid indigestion

  • WARNINGS

    Warnings:

    Do not:

    •Take more than 18 tablets in a 24 hour period, or use the maximum dosage of

    this product for more than 2 weeks, except under the advice of a physician.

    Stop use and ask a doctor if:

    •You are currently taking any prescription drug. Antacids may react with certain

    prescription drugs.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical

     attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and older:  Take 2 tablets every 4 to

    6 hours or as needed, do not exceed 18 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years: Consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: acacia gum, flavor, magnesium stearate, maltodextrin, starch and sugar.

  • PRINCIPAL DISPLAY PANEL

    Mint Carton

  • INGREDIENTS AND APPEARANCE
    MINT ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code FR8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-303-68100 in 1 CARTON04/07/2015
    1NDC:67060-303-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/07/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(67060-303)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-303)
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