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

  • NDC Code(s): 68391-597-12
  • Packager: BJWC (Berkley & Jensen / BJ's)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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

View All Sections
  • 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 except under the advise and supervision of a physician
  • Other information

    • store between 20-25ºC (68-77º)
    • 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, mannitol,  peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide


  • Questions or comments?

    Call toll free 1-800-934-1204 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

    ANTIGAS

    FAST RELIEF OF

    • PRESSURE
    • BLOATING
    • DISCOMFORT

    SOFTGELS

    SMALL, EASY TO SWALLOW

    †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.

    Distributed by

    BJ's Wholesale Club

    25 Research Drive

    Westborough, MA 01581

  • Product Label

    Simethicone 125 mg

    BERKLEY JENSEN (BJ's Extra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-597
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-597-12120 in 1 CARTON10/30/2019
    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 DrugM01610/30/2019
    Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!