ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]

ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]
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NDC 49035-585-21
Set ID 206d57ec-c854-496e-af53-7d8b2a208d85
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
Generic Name
Product Class
Product Number
Application Number PART332
  • 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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