Label: CALCIUM CARBONATE- calcium carbon 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 May 24, 2012

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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

  • Principal Display Panel

    CALCIUM

    Antacid Tablets

    Regular Strength

    ANTACID/CALCIUM SUPPLEMENT

    Calcium Carbonate 500 mg

    Assorted Fruit

    Naturally & Artificially Flavored

    Bottles of 60
    		NDC 54868-2399-1

    image of package label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbon tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2399(NDC:0904-1258)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) 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:54868-2399-160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/23/1996
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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