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

  • NDC Code(s): 0536-1306-08
  • Packager: Rugby Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    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 symptoms occur
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store between 15-30ºC (59-86ºF)
    • protect from heat and moisture
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin

  • Questions or comments?

    Call 1-800-645-2158

  • Principal Display Panel

    Compare to the active ingredient in Phazyme® Ultra Strength†

    Ultra Strength

    Simethicone 180 mg

    Antigas

    Fast relief of

    • Gas
    • Pressure
    • Bloating
    • Discomfort

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

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

    Distributed by:

    RUGBY® LABORATORIES

    Livonia,  MI 48152

    www.rugbylaboratories.om

    .

  • Product Label

    Simethicone 180 mg

    RUGBY Ultra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1306
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code 05A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1306-0860 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00207/24/2020
    Labeler - Rugby Laboratories, Inc. (079246066)
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