Label: LEADER ULTRA STRENGTH ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 70000-0436-1
  • Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
  • 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 10, 2022

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  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 1000 mg

  • PURPOSE

    Antacid

  • USE(S)

    relieves:

    • acid indigestion
    • heartburn
  • 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 a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

  • IF PREGNANT OR/BREASTFEEDING,

    ask a health professional before use.

  • 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.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 400 mg
    • do not use if printed seal under the cap is torn or missing
    • store at room temperature. keep the container tightly closed.
  • INACTIVE INGREDIENTS

    adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    LEADER™
    NDC 70000-0436-1
    Ultra Strength
    Antacid
    Tablets

    Calcium Carbonate 1000 mg
    Assorted Berry Flavor

    Relief of:
    Heartburn and
    Acid Indigestion

    COMPARE TO TUMS® ULTRA STRENGTH active ingredient*

    72 CHEWABLE TABLETS



    118
  • INGREDIENTS AND APPEARANCE
    LEADER ULTRA STRENGTH ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0436
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBLUE, PINK, PINK (PINKISH BLUE) Scoreno score
    ShapeROUNDSize17mm
    FlavorBERRY (STRAWBERRY, RASPBERRY, WIDBERRY) Imprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0436-172 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33107/10/2019
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70000-0436)
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