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 8, 2023

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  • 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(68210-0314)
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