Label: CAREONE REGULAR STRENGTH CALCIUM ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 72476-022-17
  • Packager: Retail Business 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 November 21, 2022

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  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 500 mg

  • PURPOSE

    Antacid

  • USE(S)

    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 15 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.

  • IF PREGNANT OR BREAST FEEDING,

    ask a health professional before use.

  • 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.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 200 mg
    • do not use if printed seal under the cap is torn or missing.
    • store at room temperature. keep the container tightly closed.
  • INACTIVE INGREDIENTS

    corn starch, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    NDC 72476-022-17

    CAREone
    compare to the active ingredient in Tums® Regular Strength 500 Peppermint*

    REGULAR STRENGTH
    CALCIUM ANTACID 
    Calcium Carbonate 500 mg
    Peppermint Flavor


    Fast Relief of:
    Heartburn and Acid Indigestion


    Gluten Free


    150 CHEWABLE TABLETS

    100

  • INGREDIENTS AND APPEARANCE
    CAREONE REGULAR STRENGTH CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code G113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-022-17150 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33110/12/2021
    Labeler - Retail Business Services, LLC. (967989935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(72476-022)
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