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

  • NDC Code(s): 41250-487-21, 41250-487-72
  • Packager: MEIJER, 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 January 17, 2023

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  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    • do not exceed 4 softgels in 24 hours unless directed by a doctor
  • Other information

    • store between 15-30°C (59-86°F)
    • do not refrigerate 
    • protect from light, heat, and moisture
  • Inactive ingredients

    D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

    * contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

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

    EXTRA STRENGTH

    Gas Relief

    Simethicone |125 mg

    Anti-Gas

    Fast Acting

    Relieves: Bloating, Pressure, Discomfort

    Softgels

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

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • Product Label

    Simethicone 125 mg

    MEIJER Extra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-487
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO;SCU;L125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-487-2150 in 1 CARTON03/31/201603/31/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41250-487-7272 in 1 CARTON03/31/201603/31/2025
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/201603/31/2025
    Labeler - MEIJER, INC. (006959555)
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