GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM]

GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM]
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NDC 68016-643-30
Set ID 2fd420ab-d3ce-4ce6-806c-2da4bec3e2f6
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredient (in each liquid-filled capsule)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    relieves bloating, pressure, fullness, or stuffed feeling 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from 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, lecithin, mineral oil, peppermint oil, purified water, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Premier
    Value®

    NDC 68016-643-30

    *COMPARE TO THE ACTIVE INGREDIENT IN
    GAS-X® EXTRA STRENGTH

    Extra Strength
    Gas Relief
    Simethicone 125 mg

    ANTIGAS

    Relieves
    • Pressure
    • Bloating
    • Discomfort

    easy to swallow

    30 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 Novartis Consumer Health, Inc.,
    owner of the registered trademark Gas-X® Extra Strength.
    50844               ORG091466401

    Product of China
    Packaged and Quality Assured in the USA

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL  33431

    If for any reason you are not satisfied with
    this product, please return it to the store
    where purchased for a full refund.

    Premier Value 44-664

    Premier Value 44-664

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-643
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 664
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-643-303 in 1 CARTON03/01/201502/04/2023
    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 FINALpart33203/01/201502/04/2023
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(68016-643)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(68016-643)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(68016-643)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(68016-643)

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