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
  • 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)

    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

    NDC 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 FINALpart33206/07/2019
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70000-0434)
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