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

  • NDC Code(s): 36800-963-50
  • Packager: TOP CARE (Topco Associates 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 November 28, 2022

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Use

    For the relief of

    • pressure and bloating commonly referred to as gas
  • Warnings

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

  • Directions

    • adult: swallow with water 1 or 2  softgels as needed after meals and at bedtime
    • do not exceed 2 softgels in 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?

    Calltoll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT*

    ULTRA STRENGTH

    Gas Relief

    ANTI-GAS/SIMETHICONE, 180 mg

    FAST RELIEF OF

    • Bloating
    • Pressure
    • Fullness & Gas

    SOFTGELS

    **This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra Strength.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    www.topcarebrand.com

  • Package Label

    Simethicone 180 mg

    TOPCARE HEALTH Ultra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-963
    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
    ShapeOVALSize12mm
    FlavorImprint Code 05A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-963-5050 in 1 BOX07/30/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33207/30/2020
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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