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 October 1, 2014

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  • Active ingredient (in each tablet)

    Calcium carbonate 750 mg

  • Purpose

    Antacid

  • KEEP OUT OF REACH OF CHILDREN


  • Uses

    relieves

    • acid indigestion
    • heartburn
  • 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 10 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 cap is torn or missing.
    • store at room temperature.
  • Inactive ingredients

    corn starch, crospovidone, red 27 lake, yellow 10 lake, dextrose, yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

  • Principal Display Panel

    Select Brand

    Antacid Tablets

    Extra Strength

    TROPICAL FRUIT

    Compare to the Active ingredient in TUMS® EX

    Naturally and Artificially Flavored

    96 CHEWABLE TABLETS

    SN

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorpink (Reddish pink) , orange, yellow, whiteScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (bananna, orange, pineapple orange, punch) Imprint Code G127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-207-3796 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/02/2009
    Labeler - Select Brand (043562370)
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