GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]

GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-188-03
Set ID bd10f0c7-a6f0-4260-bae4-fdea9c5fc081
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
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: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH GAS RELIEF 

     ANTIGAS SIMETHICONE 125 mg  15 SOFTGELS

    NDC 51013-188-03

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

    ES Gas Relief 15ct

    ES Gas Relief 15ct

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-188
    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:51013-188-031 in 1 CARTON07/17/2017
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33207/17/2017
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-188) , analysis(51013-188)

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