Label: CARE ONE CALCIUM ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 41520-468-80
  • Packager: American Sales Company
  • 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 December 14, 2018

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  • Active ingredient (in each tablet)

    Calcium carbonate USP 750mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    sour stomach
    •
    acid indigestion
    •
    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
    •
    store at 20-25°C (68-77°F)
    •
    does not meet USP for assay
  • Inactive ingredients

    dextrose, 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

  • Questions?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Tums® Extra Strength 750

    EXTRA STRENGTH

    CALCIUM ANTACID

    Calcium Carbonate 750mg

    Assorted Tropical Fruit Flavors

    Fast Relief of: Heartburn and Acid Indigestion

    Gluten Free

    96 CHEWABLE TABLETS

    CareOne Calcium Antacid
  • INGREDIENTS AND APPEARANCE
    CARE ONE CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-468
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    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)  
    Product Characteristics
    ColorYELLOW, ORANGE, WHITE, REDScoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (banana, orange, pineapple, tropical fruit punch) Imprint Code L468
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-468-8096 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/01/2004
    Labeler - American Sales Company (809183973)
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