Label: ULTRA STRENGTH GAS RELIEF- 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 October 24, 2017

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Use

     for the relief of

    • pressure and bloating 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 2 softgels in 24 hours under the advice and supervision of a physician
  • Other information

    • store at controlled room temperature 15º - 30ºC (59º - 86ºF)
    • protect from heat and moisture
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

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

  • Questions or comments?

    Call toll free: 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    Ultra Strength Gas Relief

    Simethicone 180 mg Anti-gas  50 Softgels

    NDC 49035-585-21

    *Compare to the active ingredient in Gas-X® Ultra Strength

    WM21-00-front

    WM21-00-back

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-585
    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
    Colororange (clear) Scoreno score
    Shapecapsule (oval) Size10mm
    FlavorImprint Code PC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-585-2150 in 1 BOTTLE; Type 0: Not a Combination Product10/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33210/24/2017
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(49035-585) , analysis(49035-585)
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