GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [AMERISOURCE BERGEN]

GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [AMERISOURCE BERGEN]
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NDC 46122-459-65
Set ID dcf401c3-44e4-46a4-a365-fcf9a8b0551f
Category HUMAN OTC DRUG LABEL
Packager Amerisource Bergen
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredient (in each liquid-filled capsule)

    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 capsules as needed after meals and at bedtime
    • do not exceed 4 capsules in 24 hours unless directed by a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    NDC 46122-459-65

    Compare to
    Gas-X® Extra Strength
    active ingredient*

    GOOD 
    NEIGHBOR
    PHARMACY®

    Extra Strength

    Gas Relief
    simethicone 125 mg

    Anti-Gas

    Relieves:
    •Bloating
    •Pressure
    •Discomfort

    Easy to Swallow

    30 Capsules
    Liquid-filled
    125 mg Each

    Actual Size

    *This product is not manufactured or distributed by Consumer Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.    

    50844       REV0419A66401

    ABC#: 10182646

    Product of China
    Packaged and Quality
    Assured in the USA

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087
    Questions or Concerns?
    www.mygnp.com

    Good Neighbor Pharmacy 44-664

    Good Neighbor Pharmacy 44-664

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-459
    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)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    Colorgreen (opaque) Scoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 664
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-459-652 in 1 CARTON03/01/201510/16/2022
    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 finalpart33203/01/201510/16/2022
    Labeler - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(46122-459)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(46122-459)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(46122-459)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(46122-459)

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