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

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

Drug Label Information

Updated January 3, 2024

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  • Active ingredient(in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

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

  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    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 20° to 25°C (68° to 77°F)

    ■ protect from light, heat and moisture

  • Inactive ingredients

    FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.

  • Questions?

    call toll free 1-866-933-6337

  • PRINCIPAL DISPLAY PANEL

    01 LBL_(DF)_Gas Relief_Simethicone_125mg_365ct

    01b LBL_(PDP) Gas Relief_Simethicone_125mg_365ct

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code YH3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-301-36365 in 1 BOTTLE09/20/2021
    11 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00209/20/2021
    Labeler - YYBA CORP (006339772)
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