Label: LEADER ANTACID REGULAR STRENGTH- 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 January 22, 2021

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  • Active ingredient (in each tablet)

    Calcium carbonate USP 500 mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    sour stomach
    •
    acid indigestion
  • 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
    •
    do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

  • Directions

    Chew 2 to 4 tablets as symptoms occur or as directed by a doctor.

  • Other information

    •
    Store below 30°C (86°F)
    •
    Keep the container tightly closed
    •
    For calcium and magnesium content see Supplement Facts.

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

  • Inactive ingredients

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

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    LEADER®

    NDC 37205-210-47

    Compare to Tums® active ingredient

    REGULAR STRENGTH

    Antacid Tablets

    Antacid/Calcium Supplement

    Calcium Carbonate 500 mg

    Fast Relief

    Relieves: Acid Indigestion, Sour Stomach, Heartburn

    Naturally and Artificially Flavored

    Peppermint Flavor

    150 Chewable Tablets

    SATISFACTION GUARANTEED

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

    Distributed By: Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    CIN 1783497

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

    Leader Regular Strength Antacid 150 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    LEADER ANTACID  REGULAR STRENGTH
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 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
    ShapeROUNDSize17mm
    FlavorPEPPERMINTImprint Code L485
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-210-47150 in 1 BOTTLE; Type 0: Not a Combination Product08/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/20/2019
    Labeler - Cardinal Health (097537435)
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