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

  • NDC Code(s): 69168-434-01, 69168-434-50, 69168-434-98
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 24, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient(s)

    Simethicone 250 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

    • store at room temperature (59°– 86°F) 15°– 30°C
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    D&C red #33, FD&C blue #1, 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  MAXIMUM STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-434
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code PC31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-434-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2021
    2NDC:69168-434-98200 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2022
    3NDC:69168-434-5050 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00201/11/2016
    Labeler - Allegiant Health (079501930)