FDA.reportPublic FDA data

SILYBUM MARIANUM SEED Extract

Manufacturer
Paradigm Pharmaceuticals Inc | BERLIN PHARMACEUTICAL INDUSTRY COMPANY LIMITED - (BRANCH)
Effective date
2024-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:01:28

Label at a glance#

ProductSILYBUM MARIANUM SEED Extract
Active ingredientMILK THISTLE
Label structure8 sections

Indications and uses

Hepatoprotection 420 mg daily divided into 3 doses for 6-8 wk. Maintenance dose: 280 mg daily.

Dosage and administration

Oral

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Maintenance dose: 280 mg daily.

Warnings 

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Oral

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

Questions? Email: customerservice@lviva.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72430-00572430-005-01, 72430-005-02, 72430-005-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MAGNESIUM STEARATE70097M6I30IACT
WATER059QF0KO0RIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
MILK THISTLEU946SH95EEACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1cf97c4e-2073-a355-e063-6394a90aa5a859178bc0-0e0c-4b7e-999f-94510cdca9182024-07-11WarningsExact identifier
spl set id: 59178bc0-0e0c-4b7e-999f-94510cdca918

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.