Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 21, 2013

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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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