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

  • NDC Code(s): 72476-897-30
  • Packager: Care One (Retail Business Services, LLC.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 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 of breast-feeding,

    ask a health professional before use.

    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 physican


  • Other information

    • store between 20-25ºC (68-77ºF)
    • do not refrigerate
    • protect from light, heat, and moisture
  • Inactive ingredients

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


  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

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

    EXTRA STRENGTH

    GAS RELIEF

    Simethicone 125 mg Antigas

    FAST RELIEF OF:

    PRESSURE,

    BLOATING

    DISCOMFORT

    SOFTGELS

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

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785 • 1-877-846-9949

  • Product Label

    Simethicone 125 mg

    CAREONE Extra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-897
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-897-3030 in 1 CARTON09/30/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/30/2019
    Labeler - Care One (Retail Business Services, LLC.) (967989935)
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