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 August 29, 2014

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  • Active ingredient (in each tablet)

    Calcium carbonate 500 mg

  • Purpose

    Antacid

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    relieves

    • acid indigestion
    • heartburn
  • WARNINGS

    Warnings

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    do not take more than 16 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

    Keep out of reach of children.

  • Directions

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

    • do not use if printed seal under the cap is torn or missing.
    • store at room temperature.
  • Inactive ingredients

    corn starch, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, sucrose, talc

  • Principal Display Panel

    Select Brand

    Anatcid Tablets

    Regular Strength

    Peppermint

    COMPARE TO ACTIVE INGREDIENT IN TUMS®

    150 Chewable Tablets

    Naturally and Artificially Flavored

    label

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-210
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code GDC113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-210-24150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/12/2008
    Labeler - Select Brand (043562370)
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