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Drugs and Health Products

Monograph: Ginseng, Panax

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 (other than TCM) must include the term "Herbal Medicine".

Date: 2009-11-04


Panax ginseng (USDA 2008)

Proper Name(s)

Panax ginseng C.A. Meyer (Araliaceae) ( USDA 2008 , McGuffin et al. 2000 )

Common Name(s)

Source Material

Root ( USP 2009 , EP 2008 , Vuksan et al. 2008 , Sievenpiper et al. 2006 , PRC 2005 , ESCOP 2003 , WHO 1999 , Bradley 1992 , BHP 1983 , Wren 1907 )

Route Of Administration


Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:



Glucose levels; Mental stress; Physical stress
Preparation: All Standardised Extracts

Dose(s): 0.5 - 9 Grams per day, dried root and/or rootlets 0.008-0.27 Grams Total ginsenosides per day
Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.5 - 9 Grams per day, dried root and/or rootlets
Preparation: Decoction

Dose(s): 3 - 9 Grams per day, dried root
Preparation: Dry

Dose(s): 3 - 9 Grams per day, steamed and dried root
Preparation: Powdered

Dose(s): 2 Grams 2 times per day, dried root

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

Consult a health care practitioner for use beyond 3 months  (Mills and Bone 2005, Blumenthal et al. 2000, McGuffin et al. 1997, Bradley 1992)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

According to TCM, do not use in cases of yin deficiency with heat signs, heat excess, or in the absence of significant qi deficiency  (Bensky and Gamble 1993)

Known Adverse Reaction(s):
Some people may experience insomnia, anxiety, or headaches, in which case, discontinue use  (Lee et al. 2008b, Vuksan et al. 2008, de Andrade et al. 2007, Sievenpiper et al. 2006, Coon and Ernst 2002, Ellis and Reddy 2002, Scaglione et al. 2001, Siegel 1979)

Non-medicinal ingredients

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


  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs: 'Ginseng' iin the British Pharmacopoeia, 'Ginseng' in the European Pharmacopoeia as well as 'Asian Ginseng', 'Powdered Asian Ginseng', 'Powdered Asian Ginseng Extract' or 'Asian Ginseng Tablets' in the U.S. Pharmacopoeia.

References cited

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

Root and/or rootlet:

  • 9 g dried root, per day (Heo et al. 2008)
  • 4.5 g dried root, per day (Lee et al. 2008b)
  • 2 g dried rootlet, 3 times per day (Vuksan et al. 2008)
  • 2-6 g dried rootlet, per day (Sievenpiper et al. 2006)
  • 1.8-9 g dried root, per day (Mills and Bone 2005)
  • 2 g powdered dried root, 2 times per day (PPRC 2005)
  • 3-9 g steamed dried root, per day (PPRC 2005)
  • 0.5-2 g dried root, per day (ESCOP 2003)
  • 1-2 g dried root, per day (Blumenthal et al. 2000)
  • 0.6-2 g dried root, per day (Bradley 1992)
  • 1-2 g dried root, 3 times per day (BHP 1983)


  • 1.8-9 g dried root, per day (Mills and Bone 2005)
  • 3-9 g dried root, per day (PPRC 2005)
  • 1-2 g dried root, per day (Blumenthal et al. 2000)
  • 0.5-2 g dried root, per day (WHO 1999)
  • 0.6-2 g dried root, per day (Bradley 1992)
  • 1-2 g dried root, 3 times per day (BHP 1983)

Fluid extract:

1-2 g dried equivalent, per day (1:1, 1-2 ml) (Blumenthal et al. 2000)


  • 0.75-3 g dried equivalent, per day (1:2, 1.5-6 ml) (Mills and Bone 2005)
  • 0.2-0.4 g dried equivalent, 3 times per day (1:5, 60% alcohol, 1-2 ml) (Hoffmann 2003)
  • 1-2 g dried equivalent, per day (1:5, 5-10 ml) (Blumenthal et al. 2000)

Standardized extracts containing 4-7% total ginsenosides:

  • 100 mg, 2 times per day (3-7:1, 40% ethanol) (Blumenthal et al. 2000; Scaglione et al. 2001; Scaglione et al. 1994; Scaglione et al. 1990; Gross et al. 1995; D'Angelo et al. 1986)
  • 200 mg, per day (3-7:1, 40% ethanol) (Reay et al. 2006; Reay et al. 2005; Kennedy et al. 2004; Kennedy et al. 2001; Allen et al. 1998; Scaglione et al. 1996; Forgo 1983)
  • 200 mg, per day (5:1) (Engels and Wirth 1997; Engels et al. 1996)
  • 400 mg, per day (5:1) (Sünram-Lea et al. 2005; Reay et al. 2005; Engels et al. 2003; Kenney et al. 2002; Scholey and Kennedy 2002; Engels et al. 2001; Kennedy et al. 2001; Engels and Wirth 1997)
  • 600 mg, per day (3-7:1, 40% ethanol) (Kennedy et al. 2001)