Label: ASSURED GAS RELIEF EXTRA STRENGTH EXTRA STRENGTH- simethicone 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 January 14, 2013

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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

    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
    • do not use if any individual blister unit is broken or missing
  • Other information

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

    D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

  • Principal Display Panel

    Compare to active ingredient in Extra Strength Gas-X®

    Extra Strength

    Gas Relief

    Simethicone 125 mg

    Anti-Gas

    Relieves:

    Bloating, Pressure, Fullness, Gas

    15 Softgels

    Assured Extra Strength Gas Relief Simethicone 125mg

    Assured Gas Relief Extra Strength

  • INGREDIENTS AND APPEARANCE
    ASSURED GAS RELIEF EXTRA STRENGTH  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0113
    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)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code R113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0113-12 in 1 CARTON
    115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/06/2012
    Labeler - Greenbrier International, Inc. (610322518)
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