AVENS - GEUM URBANUM
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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.
Notes
- Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
August 5, 2019
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation | ||
Geum urbanum |
|
Geum urbanum |
|
Dried |
References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, BHP 1983, Grieve 1971; Source materials: Williamson et al. 1988, Grieve 1971.
Route of Administration
Oral
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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
- Traditionally used in Herbal Medicine to help relieve diarrhoea (antidiarrhoeal) (Wichtl 2004; Williamson et al. 1988; BHP 1983; Grieve 1971).
- Traditionally used in Herbal Medicine to help reduce fever (febrifuge) (Williamson et al. 1988; BHP 1983; Grieve 1971).
- Traditionally used in Herbal Medicine (as an astringent) to help relieve sore throats (Wichtl 2004; Williamson et al. 1988; Grieve 1971).
- Traditionally used in Herbal Medicine to aid digestion (stomachic) (Wichtl 2004; Williamson et al. 1988; Grieve 1971).
The following combined use(s) or purpose(s) is/are also acceptable:
Traditionally used in Herbal Medicine to help reduce fever (febrifuge) and (as an astringent) to help relieve sore throats (Wichtl 2004; Williamson et al. 1988; BHP 1983; Grieve 1971).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
1 - 12 grams of dried herb top and/or root, per day (Wichtl 2004; BHP 1983; Grieve 1971).
Direction(s) for use
No statement required.
Duration(s) of Use
No statement required.
Risk Information
Caution(s) and warning(s)
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding.
Contraindication(s)
No statement required.
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
No statement required.
Specifications
- The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
- The medicinal ingredient must comply with the requirements outlined in the NHPID.
References Cited
- BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
- Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Geum urbanum. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 June 5]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
- Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.
References Reviewed
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press; 2007.
- Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
- Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines, 1st edition. Montvale (NJ): Medical Economics Company; 1998.