Label: CAREONE EXTRA STRENGTH ASSORTED FRUITS- 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 August 19, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate 750 mg

  • Purpose

    Antacid

  • Uses

    relieves:

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach associated with these symptoms
  • 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-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 swallow tablets whole
    •
    do not take for symptoms that persists for more than 2 weeks unless advised by a doctor
  • Other information

    •
    each tablet contains:elemental calcium 300 mg
    •
    store at room temperature. Keep the container tightly closed.

    SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • Inactive ingredients

    adipic acid, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6 flavors, magnesium stearate, maltodextrin, starch, sucralose

  • PRINCIPAL DISPLAY PANEL

    CAREONE™

    NDC 41520-905-90

    Compare to the Active Ingredient in TUMS® Smoothies™ EX*

    EXTRA STRENGTH

    SMOOTH ANTACID

    Calcium Carbonate USP 750 mg

    Assorted Fruit Flavors

    FOR FAST RELIEF OF:

    •
    ACID INDIGESTION
    •
    HEARTBURN
    •
    UPSET STOMACH

    90 CHEWABLE TABLETS

    GLUTEN-FREE

    DISTRIBUTED. BY:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

    © 2018 S&S Brands, LLC, Quality guaranteed or your money back.

    *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of TUMS® Smoothies™EX..

    Careone Extra Strength Smooth Antacid 90 Counts
  • INGREDIENTS AND APPEARANCE
    CAREONE EXTRA STRENGTH  ASSORTED FRUITS
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-905
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINK, RED, ORANGE, YELLOWScoreno score
    ShapeROUNDSize18mm
    FlavorFRUIT (Assorted) Imprint Code RP115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-905-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/19/2019
    Labeler - FOODHOLD USA (809183973)
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