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

  • 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 September 7, 2023

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

View All Sections
  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Uses

    For the relief of 

    • pressure and bloating 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 2 softgels in 24  hours except under the advice and supervision of a physician
  • Other information

    • store between 15-30°C (59-86°F)
    • protect from heat and moisture
  • Inactive ingredients

    FD&C red #40*, FD&C yellow #6, gelatin, glycerin

  • Questions or comments?

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

  • Principal Display Panel

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

    ULTRA STRENGTH

    GAS RELIEF

    SIMETHICONE 180 mg

    ANTI-GAS

    Fast Relief of:

    • gas
    • pressure  
    • bloating 
    • discomfort

    SOFTGELS

    †This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra 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: RITE AID,

    200 NEWBERRY COMMONS

    ETTERS, PA 17319

    www.riteaid.com

  • Package Label

    Simethicone 180 mg

    RITE AID Ultra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 05A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-4301-550 in 1 CARTON05/31/2019
    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 finalpart33205/31/2019
    Labeler - Rite Aid Corporation (014578892)
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!