Label: GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 50844-795-29, 50844-795-32
  • Packager: L.N.K. International, Inc.
  • 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 October 20, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each liquid-filled capsule)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for the relief of pressure, bloating, and fullness commonly referred to as gas

  • Warnings

    Keep out of reach of children.

  • Directions

    • adults and children 12 years and over: swallow with water 1 or 2 capsules as needed after meals and at bedtime
    • do not exceed 4 capsules in 24 hours unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
    • see end flap for expiration and lot number
  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, light mineral oil, peppermint oil, purified water, titanium dioxide, white ink

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    QUALITY PLUS

    NDC 50844-795-32

    *Compare to active ingredient
    in Gas-X® Extra Strength

    EXTRA STRENGTH
    GAS RELIEF
    Simethicone 125 mg
    ANTIGAS

    Relieves:
    • Pressure • Bloating • Discomfort

    Easy to Swallow

    120 Liquid-filled capsules

    ACTUAL SIZE

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

    *This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.
    50844      ORG022075332

    Distributed by LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788
    USA

    Product of Dubai
    Packaged and
    Quality Assured in
    the USA

    Quality Plus 44-753

    Quality Plus 44-753

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-795
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 753
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-795-29150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/2021
    2NDC:50844-795-328 in 1 CARTON05/06/2021
    215 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33205/06/2021
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(50844-795)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-795)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-795)