Label: REGULAR STRENGTH ANTACID ASSORTED FRUIT- 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

    Calcium Carbonate USP 500mg

  • 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 taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    •
    do not take more than 15 tablets in 24 hours
    •
    if pregnant do not take more than 10 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 completely 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 tablets contains: elemental calcium 200mg
    •
    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 Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, starch, sucralose.

  • Package/Label Principal Display Panel

    NDC 70000-0034-1

    COMPARE TO TUMS® REGULAR STRENGTH active ingredient*

    Regular Strength

    Antacid Tablets

    Calcium Carbonate 500mg

    Assorted Fruit Flavor

    Naturally and Artificially Flavored

    Relieves:

    Upset Stomach

    Heartburn

    Acid Indigestion

    100% Money Back Guarantee

    150 Chewable Tablets

    ©2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinals Health.

    All other marks are the property of their respective owners.

    www.myleader.com

    DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

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

    CARDINAL Regular Strength Assorted Fruit Antacid Tablets

    Cardinal Regular Strength Antacid Tablets

  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH ANTACID  ASSORTED FRUIT
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0034
    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
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED, YELLOW, ORANGE, GREENScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (Assorted) Imprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0034-1150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/16/2019
    Labeler - CARDINAL HEALTH (063997360)
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