Label: LEADER GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

  • 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 softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    relieves pressure and bloating commonly referred to as gas

  • Warnings

    Keep out of reach of children

  • Directions

    •
    do not exceed 4 softgels in 24 hours
    •
    adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • Other information

    store at 20°-25°C

  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    NDC 37205-295-65

    Compare to Gas-X® Extra Strength active ingredient*

    EXTRA STRENGTH

    Gas Relief

    Simethicone 125 mg

    Anti-Gas

    For Fast Relief of Pressure, Bloating & Discomfort

    SATISFACTION GUARANTEED

    30 SOFTGEL

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed By: Cardinal Health

    Dublin Ohio 43017

    www.myleader.com

    CIN 2788362

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

    *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X® Extra Strength.

    Extra Strength Gas Relief 30 Softgels

    Gas Relief Carton

  • INGREDIENTS AND APPEARANCE
    LEADER GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-295
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L428
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-295-653 in 1 CARTON07/18/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33207/18/2019
    Labeler - Cardinal Health (097537435)
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