GOOD SENSE GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]

GOOD SENSE GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]
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NDC 0113-0428-60
Set ID 6b2d8591-cc58-457e-92b6-c719eee85605
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    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 20-25°C (68-77°F)
    protect from light, heat and moisture
  • Inactive ingredients

    D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Extra Strength

    Anti-Gas

    Gas Relief

    Softgels

    Actual Size

    Simethicone 125 mg

    Relieves Gas Fast

    • Pressure

    • Bloating

    • Discomfort

    #1 DOCTOR RECOMMENDED

    anti-gas active ingredient

    Compare to active ingredient of Gas-X® Extra Strength

    30 Softgels

    gas relief image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0428
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L428
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0428-6020 in 1 CARTON10/28/201012/31/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0113-0428-6530 in 1 CARTON02/09/1999
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/09/1999
    Labeler - L. Perrigo Company (006013346)