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

  • NDC Code(s): 70677-0084-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 25, 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 needed after meals
    • 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT**

    GAS RELIEF

    Ultra Strength

    Antigas

    Relieves bloating, pressure, fullness & gas

    SIMETHICONE 180 mg

    RELIEVES GAS SYMPTOMS

    SOFTGELS

    †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.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by McKesson

    6555 State Highway 161 Irving, TX 75039

    www.sunmarkbrand.com

  • Product Label

    Simethicone 180 mg

    SUNMARK Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0084
    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:70677-0084-11 in 1 BOX05/29/202007/28/2025
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00205/29/202007/28/2025
    Labeler - Strategic Sourcing Services LLC (116956644)
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