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

  • NDC Code(s): 55629-021-01
  • Packager: One2Zee Limited Liability Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 25, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each softgel)

    Simethicone 125 mg

  • PURPOSE

    Purpose

    Antigas

  • INDICATIONS & USAGE

    Use for the relief of

    • pressure
    • bloating
    • fullness
    • commonly referred to as gas
  • Warning

    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 controlled room temperature 20°-25°C (68°-77°F)
    • protact from light, heat and moisture
    • do not use if imprinted safety seal under cap is broken or missing
  • INACTIVE INGREDIENT

    D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, povidone, peppermint oil, purified water, sorbitol, titanium dioxide

  • QUESTIONS

    Questions or comments?
    Call 1-833-663-2933

  • PRINCIPAL DISPLAY PANEL

    Bottle-label

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 125MG GAS RELIEF 
    simethicone 125 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code Z25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-021-01365 in 1 BOTTLE; Type 0: Not a Combination Product09/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM09/11/2024
    Labeler - One2Zee Limited Liability Company (078656111)
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