Label: SIMETHICONE capsule, gelatin coated

  • NDC Code(s): 68210-0314-5
  • Packager: Spirit Pharmaceuticals 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 March 16, 2020

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

  • 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 finalpart33203/10/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(68210-0314)