Label: GAS RELIEF SIMETHICONE 125MG SOFTGEL- simethicone capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 18, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    Use 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

    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 advice and supervision of a physician
  • Other Information

    • store at 15° to 30°C (59° to 86°F)
    • protect from light, heat, and moisture
  • Inactive Ingredients

    Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

  • Questions or Comments?

    Call 1 (718) 337-8733 or visit support@nuvicare.com

  • PRINCIPAL DISPLAY PANEL

    PL0213-00 NC-Gas Relief 125mg-100ct.jpg

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF SIMETHICONE 125MG SOFTGEL 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 911
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84324-014-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00207/18/2024
    Labeler - NUVICARE LLC (119257565)
    Registrant - NUVICARE LLC (119257565)
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

More Info on this Drug

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