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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 August 30, 2012

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  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antiflatulent

  • Uses

    for relief of:

    • bloating
    • pressure
    • fullness
    • stuffed feeling 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 or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor.
  • Other information

    • store at controlled room temperature 15o- 30o C (59o- 86o F)
    • protect from heat and moisture
    • *This product is not manufactured or distributed by Novartis Consumer Healthcare Inc., owner of the registered trademark Extra Strength Gas-X®.
  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special.

  • principal display panel

     Extra Strength Gas Relief

    ANTIGAS

    SIMETHICONE 125 mg

    Relieves:

    • bloating
    • pressure
    • fullness
    • gas

    *Compare to  Extra Strength Gas-X® active ingredient

    Packaged by: PL Developments

    200 hicks street

    westbury, NY 11590 USA

    QUESTIONS OR COMMENTS?

    call toll free 1-877-753-3935

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

  • Product Label

    SHOPKO GAS RELIEF 30 COUNT

    SIMETHICONE 125 MG

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-550
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-550-302 in 1 CARTON
    115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33206/02/2010
    Labeler - Shopko Stores Operating Co., LLC. (023252638)
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