Label: GAS RELIEF ULTRA STRENGTH- 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 April 24, 2014

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antiflatulent (Antigas)

  • Uses

    • 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 professional before use.

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels as needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician
  • Other information

    • store at 15º-30ºC (59º- 86ºF)
  • Inactive ingredients

    edible ink, FD&C yellow #6, gelatin, glycerin, purified water

  • Questions or comments?

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

  • Principal Display Panel

    *Compare to the active ingredient in Phazyme® Ultra Strength

    Ultra Strength

    Gas Relief

    Simethicone 180 mg

    Antigas

    • RELIEVES BLOATING AND FULLNESS
    • ALSO RELIEVES PRESSURE AND GAS

    Softgels

    *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

    DISTRIBUTED BY ONPOINT, INC.

    2 PARAGON DRIVE

    MONTVALE, NJ 07645

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

  • Product Label

    Simethicone 180 mg

    Simethicone 180 mg softgels

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53187-530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code S180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53187-530-601 in 1 CARTON
    160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33208/17/2010
    Labeler - LIVE BETTER (The Great Atlantic & Pacific Tea Company) (001367366)
    Registrant - P and L Development of New York Corporation (800014821)
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