Label: SUNMARK CALCIUM ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 April 8, 2014

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  • Active ingredient (in each tablet)

    Calcium carbonate 500 mg

  • Purpose

    Antacid

  • 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 prescriptiom 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 seal under cap is torn or missing
    • store at room temperature
  • Inactive ingredients

    adipic acid, corn starch, crospovidone, D and C red 27 lake, D and C red 30 lake, D and C Yellow 10 lake, dextrose, FD and C blue 1 lake, FD and C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

  • Principal Display Panel

    Sunmark

    compare to Tums active ingredient

    calcium antacid

    regular strength

    fast relief of heartburn and acid indigestion

    daily source of calcium

    assorted fruit flavors

    150 chewable tabletsLABEL

  • INGREDIENTS AND APPEARANCE
    SUNMARK CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-958
    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)  
    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
    ShapeROUNDSize16mm
    FlavorFRUIT (Orange, cherry, lemon, lime) Imprint Code GDC126
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-958-21150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/01/2011
    Labeler - McKesson (177667227)
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