Label: LEADER ULTRA STRENGTH PEPPERMINT FLAVOR- chewable antacid tablets 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

If you are a consumer or patient please visit this version.

  • Active ingredient (per tablet)

    Calcium Carbonate USP 1000mg

  • 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 7 tablets in 24 hours
    if pregnant do not take more than 5 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 2-3 tablets as symptoms occur, or as directed by a doctor
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    each tablet contains: elemental calcium 400mg
    store at room temperature. Keep container tightly closed.
  • Inactive ingredients

    dextrose, flavors, magnesium stearate, maltodextrin, starch, sucralose.

    Questions?

    1-866-467-2748

    Safety sealed: Do not use if printed seal under cap is torn or missing

  • Package/Label Principal Display Panel

    LEADER

    NDC 70000-0459-1

    COMPARE TO TUMS® ULTRA STRENGTH active ingredient*

    Ultra Strength

    Antacid Tablets

    Calcium Carbonate USP 1000mg

    Peppermint Flavor

    Naturally and Artificially Flavored

    Relief of:

    Upset stomach

    Heartburn

    Acid indigestion

    100% Money Back Guarantee

    72 CHEWABLE TABLETS

    GLUTEN- FREE

    © 2018 Cardinal Health. All Right Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All others marks

    are the property of their respective owners.

    DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

    100% Money Back Guarantee

    Return to place of purchase.

    *This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, TUMS® Ultra Strength.

    LEADER ULTRA STRENGTH ANTACID CHEWABLE TABLETS
  • INGREDIENTS AND APPEARANCE
    LEADER ULTRA STRENGTH  PEPPERMINT FLAVOR
    chewable antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0459
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code L962
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0459-172 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/18/2018
    Labeler - Cardinal Health (063997360)