Label: SOUND BODY CALCIUM 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 June 18, 2018

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  • Active ingredient (in each tablet)

    Calcium carbonate USP 750mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach associated with these symptoms
  • Warnings

    Ask a doctor before use if you have

    •
    kidney stones
    •
    a calcium-restricted diet
  • 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 24 hours
    •
    if pregnant do not take more than 6 tablets in 24 hours
    •
    do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
  • Keep out of reach of children.

  • Directions

    •
    adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor
    •
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    •
    each tablet contains: calcium 320mg and magnesium 2mg
    •
    store at 20-25°C (68-77°F). Keep the container tightly closed.
    •
    does not meet USP for assay
  • Inactive ingredients

    citric acid, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake, flavors, glycerin, magnesium stearate, maltodextrin, mineral oil, sucralose

  • Questions?

    1-800-719-9260

  • Principal Display Panel

    Compare to the Active Ingredient in Tums® Smoothies™ Extra Strength 750

    EXTRA STRENGTH

    750

    Calcium

    Antacid

    Calcium Carbonate 750 mg

    Smooth Dissolve

    Assorted Fruit Flavored

    60 CHEWABLE TABLETS

    calcium-antacid-image
  • INGREDIENTS AND APPEARANCE
    SOUND BODY CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-028
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINK (cherry, strawberry) , ORANGE (orange) , YELLOW (lemon) Scoreno score
    ShapeROUNDSize19mm
    FlavorFRUITImprint Code L9Y7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50594-028-7260 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/15/2018
    Labeler - Big Lots Stores, Inc. (017885351)
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