Label: CHERRY ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 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 asdirected by a doctor.

    Children under 12 years: Consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: acacia gum, FD&C Red #40, flavor, magnesium stearate, maltodextrin, and sugar.

  • PRINCIPAL DISPLAY PANEL

    Cherry Antacid 250ct Box

  • INGREDIENTS AND APPEARANCE
    CHERRY ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-304
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorpink (ROSE PINK) Scoreno score
    ShapeROUNDSize12mm
    FlavorCHERRYImprint Code FR8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-304-68100 in 1 CARTON04/07/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67060-304-67250 in 1 CARTON04/07/2015
    22 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(67060-304)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-304)
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