Label: LEADER GAS RELIEF- simethicone tablet, chewable

  • NDC Code(s): 70000-0434-1
  • Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • ACTIVE INGREDIENT(in each tablet)

    Simethicone 80 mg

  • PURPOSE

    Antigas

  • USE(S)

    relieves:


    • pressure
    • bloating
    • symptoms referred to as gas
  • WARNINGS

    .

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center immediately. 

  • DIRECTIONS

    • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
    • do not exceed 6 tablets per day unless directed by a physician
  • OTHER INFORMATION

    • do  not use if inner seal is broken
    • store at room temperature
    • avoid high humidity and excessive heat, above 40oC (104oF)
  • INACTIVE INGREDIENTS

    compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

  • PRINCIPAL DISPLAY PANEL

    DC 70000-0434-1
    LEADER™
    Gas Relief

    Simethicone, 80 mg
    Antigas
    Mint Flavor

    For Relief of :
    Pressure, Bloating, Symptoms Referred to as Gas

    100 CHEWABLE TABLETS

    119

  • INGREDIENTS AND APPEARANCE
    LEADER GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0434
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUGARCANE (UNII: 81H2R5AOH3)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code G103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0434-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00206/07/2019
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70000-0434)
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