Label: GAS RELIEF- simethicone capsule, gelatin coated

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

Drug Label Information

Updated January 12, 2024

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  • Active Ingredient

    (in each softgel)

    Simethicone 250mg

  • Purpose

    Anti-gas

  • Use

    relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask a doctor if

    Stop use and ask a doctor if condition persists

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels as symptoms occur
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other Information

    • store at room temperature 15ºC to 30ºC (59ºF to 86ºF)
  • Inactive Ingredients

    DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

  • Questions?

    Call toll-free 1-800-706-5575

  • Principal Display Panel

    Cardinal Health - Leader

    Maximum Strength

    Gas Relief

    Simethicone 250 mg (anti-gas)

    60 Liquid Filled Softgels

    Bottle label

    NDC# 70000-0514-1

    60ct-bottle-lbl

  • Principal Display Panel

    Cardinal Health - Leader

    Maximum Strength

    Gas Relief

    Simethicone 250 mg (anti-gas)

    60 Liquid Filled Softgels

    Carton

    NDC# 70000-0514-1

    60ct-carton-lbl

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0514
    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)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0514-11 in 1 CARTON07/24/201909/30/2024
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00207/24/201909/30/2024
    Labeler - Cardinal Health (063997360)
    Registrant - Apotex Inc. (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Ontario Limited248441727analysis(70000-0514) , manufacture(70000-0514)
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