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 2, 2014

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  • Active ingredient (in each tablet)

    Calcium carbonate 1000 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 8 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

    adipic acid, corn starch, crospovidone, red 27 lake, red 30 lake, yellow 10 lake, dextrose, blue 1 lake, yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

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    Compare to the active ingredient in TUMS® ULTRA

    Antacid Tablets

    Ultra Strength

    Assorted Fruit

    Naturally and Artificially Flavored

    72 CHEWABLE TABLETS

    Ultra Assoted Fruit front label

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-955
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colororange, yellow, green, pink (reddish-pink) Scoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (orange, cherry, lemon, lime) Imprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-955-7272 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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