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 September 25, 2012

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

  • Principal Display Panel

    Compare to Extra Strength Gas-X® active ingredient*

    Gas Relief

    Extra Strength

    • Discomfort
    • Pressure
    • Bloating

    Simethicone 125 mg

    Relieves gas symptoms

    *This product is not manufactured or distributed by Novartis consumer health, Inc., owner of the registered trademark Extra strength Gas-X®

    Another quality product distributed by McKesson

    one post street, San Francisco, CA 94104

    Money back gurantee

    Please visit us at www.sunmarkbrand.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.


  • Product Label

     Sunmark gas relief extra strength

    Simethicone 125 mg

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-946
    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:49348-946-442 in 1 BOX
    115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34704/12/2011
    Labeler - McKesson (Sunmark) (177667227)
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