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

GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]
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NDC 49035-583-64
Set ID 69351cf9-3092-45ca-8b84-83e3737fa8d4
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
Generic Name
Product Class
Product Number
Application Number PART332
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for the relief of

    • pressure, bloating, and fullness 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 4 softgels in 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

  • Questions or Comments?

    Call: 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH GAS RELIEF 

     ANTIGAS SIMETHICONE 125 mg  150 SOFTGELS

    NDC 49035-583-64

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

    Walmart ES Gas Relief 150ct

    Walmart ES Gas Relief 150ct

    Walmart ES Gas Relief 150ct

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-583
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (opaque) Scoreno score
    Shapecapsule (oval) Size10mm
    FlavorImprint Code PC2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-583-64150 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/18/2017
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(49035-583) , analysis(49035-583)

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