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

ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-428-09
Set ID 247fcde0-aec5-4e1d-b202-95785aa7f72a
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 180 mg

  • Purpose

    Antigas

  • Uses

      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 except under the advice and supervision of a physician
  • Other information

    • store at controlled room temperature 15º - 30ºC (59º - 86ºF)
    • protect from heat and moisture
  • Inactive ingredients

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

  • Questions or comments?

    Call: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Ultra Strength Gas Relief

    Simethicone 180 mg Antigas  50 Softgels

    NDC 51013-428-09

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

    Ultra Strength Gas Relief 50ct

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-428
    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:51013-428-095 in 1 CARTON02/08/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/08/2018
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-428) , analysis(51013-428)

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