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Pill Identifier Information of Simethicone 180 MG Oral Capsule

Drug Information

Simethicone 180 MG Oral Capsule

Imprint: P10
Shape: C48345
Color: C48331
Ingredients: Simethicone
Size: 10.00
Score: 1
Rxtty: SCD
Author: SPIRIT PHARMACEUTICALS,LLC
Inactive Ingredients: GLYCERIN / GELATIN / TITANIUM DIOXIDE / SORBITOL / WATER / HYPROMELLOSE / FD&C YELLOW NO. 6 / PEPPERMINT OIL>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per 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.

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

    FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SIMETHICONE CAPSULES USP 180MG
    Each Softgel Contains:

    (Simethicone USP 180 mg)

    LOT NO :

    MFG DATE :

    GROSS WT. :

    NDC NO :         68210-1902
    QUANTITY :

    EXP DATE :

    CRTN :

    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 - Shipping Label
  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    dimethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code P10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1902-11 in 1 BOX
    110 in 1 BAG
    2NDC:68210-1902-21 in 1 BOX
    230 in 1 BAG
    3NDC:68210-1902-31 in 1 BOX
    31000 in 1 BAG
    4NDC:68210-1902-41 in 1 BOX
    416000 in 1 BAG
    5NDC:68210-1902-51 in 1 BOX
    520000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart310.54510/01/2009
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE