Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 55629-010-01, 55629-010-02
  • Packager: ONE2ZEE LIMITED LIABILITY COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 25, 2023

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  • Active ingredient (in each softgel)

    Simethicone 125mg

  • Purpose

    Antigas

  • Use

    for the relief of

    • pressure, bloating, and 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 20-25ºC (68-77ºF)
    • protect from light, heat, and moisture
  • Inactive ingredients

    FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    IMETHICONE CAPSULES, 325 mg

    Quantity : 48 Bags of 1500 Capsules each
    NDC. No : 55629-010-01

    Important:

    1. Inspect immediately upon receipt

    2. This is bulk shipment intended for further processing only

    3. store at controlled room temperature 20-25ºC (68-77ºF), protect from light, heat, and moisture

    shipping label

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-010
    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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Povidone K30 (UNII: U725QWY32X)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code YH3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-010-0148 in 1 CARTON01/19/2021
    1NDC:55629-010-021500 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/19/2021
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medgel Private Limited677385498manufacture(55629-010)
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