EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SHOPKO STORES OPERATING CO., LLC.]

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  • EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SHOPKO STORES OPERATING CO., LLC.]

EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SHOPKO STORES OPERATING CO., LLC.]
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NDC 37012-550-30
Set ID 039c2602-39db-49a3-a535-e178a76fef3d
Category HUMAN OTC DRUG LABEL
Packager Shopko Stores Operating Co., LLC.
Generic Name
Product Class
Product Number
Application Number PART332
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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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