Label: GAS RELIEF- simethicone softgels capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Drug Facts

  • Active Ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Uses

    relives bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask a doctor if condition persists

    Keep out of reach of children

  • Directions

    • Swallow one or two softgels after a mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician

  • Other Information

    • store at room temperature 59-86°F (15-30°C)

  • Inactive ingredients

    D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • Principal Display Panel

    Topco Gas Relief Carton

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone softgels capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-733
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-733-202 in 1 CARTON07/08/2022
    110 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00207/08/2022
    Labeler - Topco Associates LLC (006935977)
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