Label: SILYBUM MARIANUM SEED EXTRACT- silymarin / extracted from seeds of silybum marianum tablet, coated

  • NDC Code(s): 72430-005-01, 72430-005-02, 72430-005-03
  • Packager: Paradigm Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 30, 2024

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  • Active Ingredient

    Silymarin (Extract from seeds of Milk Thistle (Silybum marianum) 70 mg

  • Purpose

    Acute, chronic & infective hepatitis; liver cirrhosis; non-alcoholic fatty liver disease/non-alcoholic steatohepatitis; alcoholic liver disease.

  • Uses

    Hepatoprotection 420 mg daily divided into 3 doses for 6-8 wk.

    Maintenance dose: 280 mg daily.

  • Warnings 

    Silymarin may inhibit cytochrome P450 2C9 and CYPP4503A4; but no effect on pharmacokinetics of indinavir in human studies. Silymarin may decrease blood glucose in patients with cirrhosis and diabetes.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Oral

  • Inactive Ingredients

    spray dried Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, butylated hydroxytoluene, opadry brown (85G56726), hydroxypropyl methylcellulose (hypromellose 15), propylen glycol, titanium dioxide, talcum.

  • QUESTIONS

    Questions? Email: customerservice@lviva.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    SILYBUM MARIANUM SEED EXTRACT 
    silymarin / extracted from seeds of silybum marianum tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72430-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE70 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    WATER (UNII: 059QF0KO0R)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code B70
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72430-005-013 in 1 BOX05/15/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:72430-005-0210 in 1 BOX05/15/2024
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:72430-005-0325 in 1 BOX05/15/2024
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/15/2020
    Labeler - Paradigm Pharmaceuticals Inc (080044989)
    Establishment
    NameAddressID/FEIBusiness Operations
    BERLIN PHARMACEUTICAL INDUSTRY COMPANY LIMITED - (BRANCH)661748158manufacture(72430-005)
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