GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [BJWC (BERKLEY & JENSEN / BJ'S)]

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  • GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [BJWC (BERKLEY & JENSEN / BJ'S)]

GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [BJWC (BERKLEY & JENSEN / BJ'S)]
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NDC 68391-550-12
Set ID b64e4438-27ef-410a-95f7-6bad9a13129f
Category HUMAN OTC DRUG LABEL
Packager BJWC (Berkley & Jensen / BJ's)
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active Ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antiflatulent (Antigas)

  • Use

    • relieves bloating, pressure, or fullness commonly referred to as gas.
  • Warnings

  • Stop use and ask a doctor if

    condition persists

  • If pregnant or breast-feeding,

     ask a health care professional before use

  • Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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 controlled room temperature 15°-30°C (59°-86°F)
    • protect from 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 special and titanium dioxide.

  • Questions or comments?

    call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Extra Strength Gas-X®*

    Extra Strength

    Gas Relief

    Simethicone, 125 mg

    Relieves:

    • bloating
    • fullness
    • pressure
    • gas

    *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas-X®

    DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

  • Product Label

    Berkley & Jensen extra strength Gas Relief softgels

    Simethicone 125 mg

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-550
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-550-128 in 1 CARTON
    115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33207/15/2013
    Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
    Registrant - P and L Development of New York Corporation (800014821)
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