Label: SIMETHICONE- dimethicone capsule, liquid filled

  • 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 February 9, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    for the relief of

    • pressure, bloating, and fullness commonly referred to as gas
  • Warnings

    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 a controlled room temperature 20-25°C (68-77°F)
    • protect from light, heat and moisture
  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL - 125 mg Label

    SIMETHICONE CAPSULES USP 125MG

    Each Softgel Contains:
    (Simethicone USP 125 mg)

    LOT NO:QUANTITY:
    DRUM NO:NDC NO: 68210-1901-
    MFG DATE: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.

    MANUFACTURED BY:
    SOFTGEL HEALTHCARE PVT LIMITED
    INDIA
    LABELLER CODE           : 35916
    LIC NO.                              : TN/DRUGS/00002124

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel - 125 mg Label
  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    dimethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code P10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1901-110 in 1 BOX
    2NDC:68210-1901-230 in 1 BOX
    3NDC:68210-1901-31000 in 1 BOX
    4NDC:68210-1901-416000 in 1 BOX
    5NDC:68210-1901-520000 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33203/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE
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