Label: SIMETHICONE- dimethicone capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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 (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Uses

    Relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask doctor if condition persists

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children

  • Directions

    • Swallow one or two softgels as needed after a meal
    • Do not exceed two softgels per day except under the advise and supervision of a physician
  • Other Information

    • Each softgel contains: potassium 5 mg
    • Store at 200 - 250C
  • Inactive ingredients:

    FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol

  • PRINCIPAL DISPLAY PANEL

    carton label for 180 mg

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    dimethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code RP112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48769-112-991000 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. Ltd.677111277manufacture
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