Label: GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 68210-4232-8
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • Drug Facts

  • Active Ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for the relief of • pressure, bloating, and fullness commonly referred to as gas

  • Warnings

  • Keep out of reach of children

  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

  • Other Information

    • store at controlled room temperature 20-25°C (68-77°F)
    • protect from light, heat, and moisture

  • Inactive ingredients

    FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    Cabinet Health P.B.C.

  • Principal Display Panel

    Simethicone 125 mg Pouch Front

    Simethicone 125 mg Pouch Back

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4232
    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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize8mm
    FlavorImprint Code 152
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4232-882 in 1 POUCH; Type 0: Not a Combination Product11/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00211/17/2022
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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