Label: GAS RELIEF- simethicone capsule, gelatin coated

  • 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 May 13, 2020

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

View All Sections
  • Active Ingredient

    (in each softgel)

    Simethicone 250mg

  • Purpose

    Anti-gas

  • Use

    For the relief of

    • Pressure, bloating or fullness commonly referred to as gas
  • Warnings

    Keep out of reach of children.

  • Directions

    • Adults and children 12 years and older; 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 at room temperature 20ºC to 35ºC (68ºF to 77ºF)
  • Inactive Ingredients

    DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

  • Questions or comments?

    Call toll-free 1-800-706-5575

  • Principal Display Panel

    CVS Maximum Strength

    Gas Relief

    Simethicone 250 mg (anti-gas)

    36 Liquid Filled Softgels

    Blister Carton label

    NDC# 69842-772-03

    Simethicone Maximum Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste.

    Carton-label

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-772
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-772-033 in 1 CARTON11/18/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/18/2019
    Labeler - CVS Pharmacy (062312574)
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!