Label: CARDINAL EXTRA STRENGTH SMOOTH ANTACID 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 October 4, 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-hour period
    •
    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: calcium 300 mg
    •
    store at room temperature. keep the container tightly closed.

    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.

    Questions or comments

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC 70000-0593-1

    *Compare to the active ingredient in Extra Strength Tums® Smoothies™

    Extra Strength

    Smooth antacid tablets

    Calcium Carbonate 750 mg

    Fast Relief of Upset Stomach, Heartburn, and Acid Indigestion


    Assorted Fruit

    Naturally and Artificially Flavored

    60 Chewable Tablets

    GLUTEN-FREE

    Distributed By:

    This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums® Smoothies™

    LDR Extra strength smooth antacid tablets calcium carbonate
  • INGREDIENTS AND APPEARANCE
    CARDINAL EXTRA STRENGTH SMOOTH ANTACID  ASSORTED FRUITS
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0593
    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 (light pink) , RED (light red) , ORANGE (light orange) , YELLOW (light yellow) Scoreno score
    ShapeROUNDSize18mm
    FlavorCHERRY, LEMON, ORANGE, STRAWBERRYImprint Code RP115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0593-160 in 1 BOTTLE; Type 0: Not a Combination Product09/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/27/2021
    Labeler - CARDINAL HEALTH (063997360)
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