Label: ANTI-GAS- simethicone capsule

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

Drug Label Information

Updated October 6, 2020

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  • Active ingredient(s)

    Simethicone 125mg

  • Purpose

    Anti gas

  • Use(s)

    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

    • Do not use if blister unit is torn or open 
  • Storage

    • store at room temperature 20o-25oC (68o -77oF)
    • protect from light, heat and moisture
  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil,
    purified water

    May Contain: sorbitol special, titanium dioxide, white edible ink

  • Principal Display Panel

    Anti Gas

    Anti Gas


  • INGREDIENTS AND APPEARANCE
    ANTI-GAS 
    simethicone capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-419
    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)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containSORBITOL SOLUTION (UNII: 8KW3E207O2)  
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-419-8530 in 1 BLISTER PACK; Type 0: Not a Combination Product01/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00201/28/2015
    Labeler - Marc Glassman, Inc. (094487477)
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