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

  • NDC Code(s): 59726-487-10, 59726-487-15, 59726-487-16
  • Packager: P & L Development, 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 October 26, 2021

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 of 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 15-30ºC(59-86ºF)
    • 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

    *contain 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

    relieves:

    • pressure
    • bloating
    • discomfort

    small, easy to swallow

    SOFTGELS

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

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

  • Product Label


    Simethicone 125 mg

    READYinCASE Gas Relief Softgels

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-487
    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 P;O;SCU;L125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-487-1010 in 1 CARTON01/31/201604/26/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59726-487-1515 in 1 CARTON01/31/201604/26/2024
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:59726-487-16150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201604/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/31/201604/26/2024
    Labeler - P & L Development, LLC (800014821)
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!