Monograph: Milk Thistle

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: (i) Text in parentheses is additional optional information which can be included on the Product Licence Application and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) Claims for traditional use must include the term "Herbal Medicine".
Date: 2018-08-28

NHPID name

Silybum marianum ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Silybum marianum ( USDA 2008 )

Common name(s)

Source material

Route Of administration


Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:




1 Day per day

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

Liver protectant: Use for at least 3 weeks to see beneficial effects.  (Flora et al. 1998, Magliulo et al. 1978) Support liver function: Use for at least 3 weeks to see beneficial effects.  (Flora et al. 1998, Magliulo et al. 1978)

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.  (Geier et al. 1990, Mironets et al. 1990)

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.


References cited

References reviewed

Appendix 1: Examples of dosage preparations, frequencies of use and directions for use

Dried fruit/seed:

4-9 g, per day (Mills and Bone 2000)



Fluid extract:

4-9 g dried equivalent, per day (1:1, 4-9 ml)(Mills and Bone 2000)


2-4 g dried equivalent, 3 times per day (1:5, 25% alcohol, 10-20 ml) (Mills 1993)

Preparations providing the following quantities of silymarin (calculated as silibinin/silybin):