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

  • NDC Code(s): 59726-530-10
  • Packager: P & L Development, LLC
  • 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 20, 2023

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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 15°-30°C (59°-86°F)
  • Inactive ingredients

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

  • Questions or comments?

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

  • Principal Display Panel

    Compare to the active ingredient in Phazyme® Ultra Strength†

    Ultra Strength

    Gas Relief

    Simethicone 180 mg

    Anti-gas

    Fast Relief of:

    • Pressure  • Bloating  • Discomfort

    Softgels

    Small, easy to swallow

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

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY  11590

  • Package Label

    Simethicone 180 mg

    ReadyInCase Ultra Strength Gas Relief Softgel

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (ORANGE) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code S180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-530-101 in 1 BOX09/01/201109/01/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33209/01/201109/01/2024
    Labeler - P & L Development, LLC (800014821)
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