Label: LEADER ANTACID- 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 23, 2021

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  • Active ingredient (in each tablet)

    Calcium carbonate 1000 mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    sour stomach
    •
    acid indigestion
    •
    upset stomach associated with this symptom
  • 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 7 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 3 tablets as symptoms occur
  • Other information

    •
    store below 30° (86°F) .
    •
    Keep the container tightly closed
    •
    For calcium and magnesium see Supplement Facts.
  • Inactive ingredients

    adipic acid, blue 1, dextrose, flavors, magnesium stearate, maltodextrin, red 27, starch, sucralose, yellow 6, yellow 10.

  • Questions? 1-800-719-9260

  • Principal Display Panel

    LEADER®

    Compare to Tums® Ultra 1000 active ingredient*

    ULTRA STRENGTH

    Antacid Tablets

    Antacid/Calcium Supplement

    Calcium Carbonate 1000 mg

    Fast Relief

    Relieves:

    •
    Acid Indigestion
    •
    Sour Stomach
    •
    Heartburn

    Naturally and Artificially Flavored

    Assorted Fruit Flavors

    SATISFACTION GUARANTEED

    72 CHEWABLE TABLETS

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

    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 3466521

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

    Ultra Strength Assorted Fruit 72 Chewable Antacid Tablets
  • INGREDIENTS AND APPEARANCE
    LEADER ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorYELLOW, GREEN, RED, ORANGEScoreno score
    ShapeROUNDSize20mm
    FlavorFRUIT (lime, orange, cherry, lemon) Imprint Code L595
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-333-6972 in 1 BOTTLE; Type 0: Not a Combination Product08/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/14/2019
    Labeler - Cardinal Health (097537435)
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