Label: GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 53943-753-01, 53943-753-15
  • Packager: Discount Drug Mart
  • 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 19, 2022

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  • 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 date 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

    DISCOUNT
    drug
    mart
    FOOD FAIR

    NDC 53943-753-15

    MAY CONTAIN ANTI-THEFT DEVICE

    EXTRA STRENGTH
    Gas Relief
    simethicone 125 mg
    Anti-Gas

    RELIEVES
    •Bloating   • Pressure    • Discomfort

    Easy to Swallow

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

    Actual Size

    50 Capsules
    Liquid-filled

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

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

    50844    ORG022075315

    Product of Dubai
    Package and Quality
    Assured in the USA

    DISTRIBUTED BY:
    DRUG MART - FOOD FAIR
    211 COMMERCE DRIVE
    MEDINA, OH 44256
    www.discount-drugmart.com

    SATISFACTION GUARANTEED
    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
    TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
    STORE, SEND REASON FOR DISSATISFACTION, NAME,
    ADDRESS AND EMPTY PACKAGE TO:
    DISCOUNT DRUG MART
    211 COMMERCE DRIVE, MEDINA, OHIO 44256
    Drug Mart 44-753

    Drug Mart 44-753

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-753
    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:53943-753-155 in 1 CARTON12/04/202006/10/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:53943-753-012 in 1 CARTON12/04/202006/10/2023
    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 finalpart33212/04/202006/10/2023
    Labeler - Discount Drug Mart (047741335)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(53943-753)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(53943-753)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(53943-753)
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