Label: ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 November 27, 2011

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  • Active ingredient (in each tablet)

    Calcium carbonate USP 500mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these symptoms
  • 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

    • now taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 15 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

  • Directions

    • chew 2 - 4 tablets as symptoms occur, or as directed by a doctor
  • Other information

    • each tablet contains: calcium 215 mg and magnesium 5 mg
    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake

  • Questions?

    1-800-616-2471

  • ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE

    Label Image
  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-1258(NDC:0904-1258)
    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
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorRED, YELLOW, GREEN, ORANGEScoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (Cherry, lemon, lime, orange) Imprint Code L478
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64725-1258-1150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/07/1992
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-1258) , REPACK(64725-1258)
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