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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.



June 3, 2019

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s) Preparation(s)

Hydrastis canadensis

  • Goldenseal
  • Orangeroot
  • Yellow-puccoon
  • Yellow root

Hydrastis canadensis

Root and rhizome


References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, Wiersema and León 1999; Source information: Blumenthal 2003, Hoffmann 2003, Bradley 1992.

Route of Administration


Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Herbal Medicine to help alleviate infectious and inflammatory conditions of the digestive tract such as gastritis and digestive upset such as dyspepsia (Mills and Bone 2005; Boon and Smith 2004; Bradley 1992; Ellingwood 1983; Wren 1907; Grieve 1971).


Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".



Adults 18 years and older


Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

0.6 - 3 grams of dried root and rhizome, per day (Mills and Bone 2005; Boon and Smith 2004; Hoffmann 2003; Bradley 1992)

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)


Do not use this product if you are pregnant or breastfeeding (Barnes and al. 2007; Mills and Bone 2005; Boon and Smith 2004; Hoffmann 2003; Brinker 2001; Bradley 1992).

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).


References Cited

References Reviewed