Label: CARDINALEXTRA STRENGTH ANTACID WINTERGREEN FLAVOR- 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 3, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    sour stomach
    •
    acid indigestion
    •
    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 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 persist for more than 2 weeks unless advised by a doctor
  • Other information

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

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

  • Inactive ingredients

    D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavor, magnesium stearate, maltodextrin, starch, sucralose

  • Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    NDC# 70000-0592-1

    Compare to the active ingredient in Extra Strength Tums®

    EXTRA STRENGTH

    Antacid Tablets

    Calcium Carbonate 750 mg

    Fast Relief of Upset Stomach, Heartburn, and Acid Indigestion

    Wintergreen

    Naturally and Artificially Flavored

    96 Chewable Tablets

    GLUTEN FREE

    K PAREVE

    Distributed By

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

    LDR Extra Strength Calicium Carbonate 96 chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CARDINALEXTRA STRENGTH  ANTACID WINTERGREEN FLAVOR
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0592
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorGREEN (Mottled) Scoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code RP102
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0592-196 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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