Label: SUNMARK CALCIUM ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 49348-055-39
  • Packager: Strategic Sourcing Services LLC
  • 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 6, 2022

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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

    • presently 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

    • store at room temperature. 
    • Phenylketonurics: contains phenylalanine, less than 1 mg per tablet
  • Inactive ingredients

    adipic acid, aspartame, FD&C yellow 6 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

  • PDP

    sunmark

    COMPARE TO THE ACTIVE INGREDIENT IN TUMS® E-X SUGAR FREE*

    NDC 49348-055-39

    sugar free

    antacid tablets

    Extra strength

    calcium carbonate 750 mg

    Fast relief of heartburn & acid indigestion

    Natural and Artificial Flavor

    ORANGE FLAVOR

    80 Chewable Tablets

    image description

  • INGREDIENTS AND APPEARANCE
    SUNMARK CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-055
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    ASPARTAME (UNII: Z0H242BBR1)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize16mm
    FlavorORANGEImprint Code G174
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-055-3980 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/24/2019
    Labeler - Strategic Sourcing Services LLC (116956644)
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