Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 55629-017-01, 55629-017-02
  • Packager: ONE2ZEE LIMITED LIABILITY COMPANY
  • 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 25, 2023

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  • Active ingredient (in each capsule)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Uses

    • relieves bloating, pressure or fullness commonly referred to as gas
  • Warnings

    Stop use and ask a doctor if

    condition persists

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels after a meal
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other Information

    • store at room temperature 59°-86°F (15°-30°C
  • Inactive ingredients

    gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40, povidone k30, titanium dioxide, water

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Simethicone capsules

    Each Softgel Contains:
    (Simethicone 250mg)

    LOT NO:
    DRUM NO:
    MFG DATE:
    QUANTITY:
    NDC NO: 55629-017-
    EXP DATE:

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
    THE F.D & C.ACT AND REGULATIONS THEREUNDER.

    Shipper label

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-017
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Povidone K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapecapsuleSize13mm
    FlavorImprint Code IS9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-017-0148 in 1 CARTON03/02/2021
    1NDC:55629-017-021500 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/02/2021
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medgel Private Limited677385498manufacture(55629-017)
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