Label: GAS RELIEF EXTRA STRENGTH- dimethicone 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 July 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    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 between 20-25°C (68-77°F)
    • protect from heat and moisture
  • Inactive ingredients

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

  • Questions?

    Call 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack Carton

    NDC 36800-801-67

    *Compare to the active ingredient
    in Gas-X® Extra Strength

    Extra Strength
    Gas Relief
    Softgels

    ANTIGAS / SIMETHICONE 125mg

    FAST RELIF OF

    • Bloating
    • Pressure
    • Fullness & Gas

    actual size

    50 Softgels

    PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GAS RELIEF EXTRA STRENGTH 
    dimethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-785
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 791
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-785-052 in 1 CARTON05/01/2021
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33205/01/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)
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