Label: 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 July 2, 2013

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  • Active Ingredient

    (in each chewable tablet)

    Calcium Carbonate 500 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
  • Warnings

    Ask a doctor before use if you have

    • kidney stones
    • a calcium-restricted diet

      ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

      Stop use and ask a doctor if symptoms last more than 2 weeks.

  • Keep out of reach of children.

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

  • Directions

    • chew 1-2 tablets as symptoms occurs.
    • do not take more than 8 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks
  • Other Information

    • each tablet contains: calcium 200 mg
    • store at room temperature
  • Inactive Ingredients

    Al-lakes (D&C red #27, D&C yellow # 10, FD&C blue #1, FD&C yellow # 6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

  • Questions or Comments

    Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    c6eab715-figure-01

    c6eab715-figure-02

    Calcium Carbonate 500 mg

    Antacid tablets

    NDC: 61715-058-54 – 150 COUNT

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CHERRY (UNII: BUC5I9595W)  
    LEMON (UNII: 24RS0A988O)  
    ORANGE (UNII: 5EVU04N5QU)  
    Product Characteristics
    ColorYELLOW, PINK, GREENScorescore with uneven pieces
    ShapeROUNDSize16mm
    FlavorLIME (Cherry,Lemon,Orange) Imprint Code AP;043
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-058-54150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/28/2013
    Labeler - Kinray Inc. (012574513)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063MANUFACTURE(61715-058)
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