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 June 29, 2012

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  • Active ingredient (per soft gel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    Relieves pressure and bloating commonly referred to as gas

  • Warnings

    Keep out of reach of children

  • Directions

    • Do not exceed 4 softgels in 24 hours
    • Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • Other information

    store at 200 - 250C

  • Inactive ingredients

    D and C yellow 10, FD and C blue 1, FD and C red 40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    simethicone capsules 125 mg label

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    dimethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-113
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize5mm
    FlavorImprint Code RP113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48769-113-995000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/15/2012
    Labeler - Softech Pharma Pvt. Ltd (677111277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Softech Pharma Pvt. Ltd677111277manufacture
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