Label: SIMETHICONE capsule, gelatin coated

  • NDC Code(s): 68210-0314-5
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Use

    for the relief of
    ■ pressure and bloating commonly referred to as gas

  • Warnings

    Keep out of reach of children.

  • 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 2 softgels in 24 hours except under the
    advice and supervision of a physician

  • Other information

    ■ store at controlled room temperature 20-25°C (68-77°F)
    ■ protect from heat and moisture

  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide

  • Questions or comments? 

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    ULTRA STRANGTH

    GAS RELIEF
    Simethicone 180 mg /
    anti-gas

    Fast relief of:
    • bloating
    • pressure
    • fullness
    • gas

    50 SOFTGELS

    image description

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0314
    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 YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (OPAQUE) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 161
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0314-51 in 1 CARTON03/10/2020
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00203/10/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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!