SOURCE- HEALTH CANADA: Compendium of Medicinal Ingredients Nomenclature
Drugs and natural health products
Product Monograph: 5-star ginseng/from America/Quinquefolius
The purpose of this monograph is to serve as a guide for industry in the preparation of product licence licence (DLMM) applications and labels for the purpose of obtaining a product product product. It is not intended to be an in-depth study of the medicinal ingredient. Note: Parentheses contain (optional) information items that can be included in the MMDD or on the product label at the discretion of the applicant. The forward slash (/) indicates that the terms and/or statements are synonymous. The applicant may use any of the terms or statements indicated.
Name of NHPID
Panax quinquefolius (USDA 2008)
Panax quinquefolius L. (Araliaceae) (USDA 2005)
- Ginseng with five leaflets
- American ginseng
Material of origin
Panax quinquefolius is a species at risk in the wild; the only acceptable source material is the root of cultivated plants (EC 2009). See specifications for more details.
Route of administration
- Foods or food-like dosage forms such as bars, chewing gum or beverages are excluded from this monograph.
- Acceptable dosage forms include, but are not limited to, strips, capsules, tablets, chewable dosage forms (e.g., tablets, gummies), liquids or powders.
Recommended use(s) or purpose(s)
Statement(s) specifying the following:
- Used in Traditional Chinese Medicine (TCM) for insufficient Qi and Yin, for internal heat, for cough, for the presence of blood in mucus, for fire during insufficiency syndrome, for dysphoria and fatigue, for thirst, dry mouth and throat
- Used in herbal medicine/herbalism as a supportive therapy to help control glucose levels
- Traditionally used in herbal medicine/herbalism to help relieve nervousness (mild sedative)
- Traditionally used in herbal medicine/herbalism to help relieve nerve dyspepsia / to aid digestion in cases of nervousness and/or stress
- Used in herbal medicine/herbalism as an adaptogen to help maintain the health of the immune system
Dose(s): 2.4 – 9 Grams per day, dried root
Instructions for use:Prepare the dried root as a decoction
Glucose levels; Mild sedative; Nervousness; Immune system
Preparation: Dry, powder, decoction and infusion + dry extracts, liquid extract, tincture, fluid extract
Dose(s): 0.5 – 12 Grams per day, dried root
Duration of use
Statement not required
Mention of risks
Statement(s) specifying the following:
Precaution(s) and warning(s):
- If you have diabetes, consult a health care practitioner before using it
- If you are taking blood thinners or digoxin, consult a health care practitioner before using them
Statement not required
Known adverse reaction(s):
Statement not required
Must be selected from the current Natural Health Products Ingredient Database and must meet the restrictions defined in the database.
- Finished product specifications must be established in accordance with the requirements outlined in the NHPD’s Natural Health Product Quality Reference Guide.
- The medicinal ingredient must comply with the requirements set out in the Natural Health Products Ingredient Database (NHPID).
- The medicinal ingredient may conform to the specifications set out in the American Ginseng, Powdered American Ginseng monographs of the U.S. Pharmacopoeia (USP 38).
- Proof of purchase or a permit to own the Panax quinquefolius crop must be available as the plant is a species at risk in the wild: (i) Panax quinquefolius is protected in Canada under the Species at Risk Act (SARA). According to section 32(2) of the Act, it is prohibited to possess, collect, buy, sell or trade any individual – including part of an individual or a product deceased from it – of a wildlife species listed as extirpated, endangered or threatened (JC 2015), (ii) Panax quinquefolius is protected in Quebec by the Act respecting threatened or vulnerable species (LEMV). This law prohibits harming, possessing, trading in, or disturbing the habitat of this species (EC 2015).
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