GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [BETTER LIVING BRANDS, LLC]

GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [BETTER LIVING BRANDS, LLC]
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NDC 21130-864-15
Set ID c8049106-5fe3-4ef2-8fe7-d9a0ad69324f
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
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

    Signature™
    care

    Quality
    Guaranteed

    COMPARE TO
    Gas-X®
    Extra Strength
    active ingredient*

    NDC 21130-864-15

    Extra Strength

    Gas Relief

    SIMETHICONE 125 mg

    Antigas

    Relief of:
    • Bloating
    • Pressure
    • Fullness
    • Gas

    Actual Size

    50 LIQUID-FILLED
    CAPSULES

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

    *This product is not manufactured or distributed
    by GSK Consumer Healthcare S.A., distributors of
    Gas-X® Extra Strength.
    50844        REV0419B66415
    Product of China
    Packaged and Quality Assured in the USA

    DISTRIBUTED BY 
    BETTER LIVING BRANDS LLC.
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100% GUARANTEED
    OR YOUR MONEY BACK.

    Signature Care 44-664

    Signature Care 44-664

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-864
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 664
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-864-155 in 1 CARTON03/01/2015
    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 finalpart33203/01/2015
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(21130-864)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(21130-864)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(21130-864)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-864)

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