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

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ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-210-60
Set ID fbea0d52-24da-4981-b0b1-729bf1cc2edd
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antiflatulent (Antigas)

  • Uses

    • relieves bloating, pressure, or fullness commonly known as gas
  • Warnings

    Stop use and ask a doctor if

    condition persists.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels as needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician
  • Other information

    • store at 15º-30ºC (59º-86ºF)
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *COMPARE TO THE ACTIVE INGREDIENT IN PHAZYME® ULTRA STRENGTH

    Ultra Strength Gas Relief

    SIMETHICONE 180 mg

    Antigas

    Fast Relief Of

    • Pressure
    • Bloating
    • Discomfort

    SOFTGELS  Small, Easy to Swallow

    *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

    DISTRIBUTED BY:

    CHAIN DRUG CONSORTIUM, LLC.

    3301 NW BOCA RATON BLVD., SUITE 101

    BOCA RATON, FL 33431

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

  • Product Label

    Simethicone 180 mg

    Premier Value Ultra Strength Gas Relief Softgel

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-210
    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
    ColorORANGEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code S180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-210-601 in 1 CARTON
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33207/08/2010
    Labeler - Chain Drug Consortium, LLC (101668460)
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