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 January 13, 2022

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  • Active ingredient (in each tablet)

    Calcium carbonate 750mg

  • Purpose

    Antacid

  • Uses

    relieves:

    acid indigestion

    heartburn

  • KEEP OUT OF REACH OF CHILDREN

  • 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.

  • 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
  • Inactive ingredients

    adipic acid, corn starch, crospovidone, d&c red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

  • PDP

    Compare to the active ingredient in TUMS EX

    Extra strength

    Alkums Antacid Tablets

    Assorted Fruit Flavors

    Calcium carbonate 750 mg

    Relieves:

    Acid indigestion

    Heartburn

    GDC LABEL

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    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
    Colorpink (reddish pink, green, yellow, orange) Scoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (cherry, lime, lemon, orange) Imprint Code G127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-127-2296 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/02/2012
    Labeler - Guardian Drug Company (119210276)
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