Monograph: Goldenseal - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's 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.
Date: 2019-06-03

NHPID name

Hydrastis canadensis ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Hydrastis canadensis ( USDA 2005 )

Common name(s)

Source material

Root and rhizome ( Blumenthal et al. 2003 , Hoffmann 2003 , Bradley 1992 ) Goldenseal is a "threatened" plant in the wild (EC 2005; JC 2003); thus only the root and rhizome from the cultivated plant are acceptable source material. See Specifications for further details.

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Dose(s):

0.6 - 3 Grams per day, dried root and rhizome

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

May take up to one week to produce beneficial effects.  (Bradley 1992)

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

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

Specifications

References cited

References reviewed

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

ORAL:

Dried root and rhizome:

Decoction:

0.5 - 1 g of dried root and rhizome, 3 times per day (Bradley 1992)

Fluid extract:

Tincture:

Solid extract:

1 g dried equivalent, 3 times per day (4:1, 0.25 g) (Boon and Smith 2004)