Label: GAS RELIEF ULTRA 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 September 24, 2021

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  • Active ingredient(s)

    Simethicone 180 mg

  • Purpose

    Anti-gas

  • Use(s)

    Relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask a doctor if

    condition persists.

    Keep out of reach of children

  • Directions

    • Swallow 1 or 2 softgels as symptoms
      occur
    • Do not exceed 2 softgels in 24 hours
      except under the advice and
      supervision of a physician.
  • Other information

    Do not use if imprinted safety seal under cap is broken or missing

  • Storage

    • store at room temperature (59°– 86°F) 15°– 30°C

  • Inactive ingredients

    FD&C yellow # 6, gelatin, glycerin,
    purified water and white edible ink

  • Questions

    Call 1-888-952-0050 Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Gas Relief

    Gas Relief


  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-433
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code PC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-433-06120 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/01/2012
    Labeler - Allegiant Health (079501930)