FDA Label for Silybum Marianum Seed Extract
View Indications, Usage & Precautions
Silybum Marianum Seed Extract Product Label
The following document was submitted to the FDA by the labeler of this product Paradigm Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.
Product Label
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