LICORICE - GLYCYRRHIZA GLABRA
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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
December 18, 2018
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation | ||
Glycyrrhiza glabra |
|
Glycyrrhiza glabra |
|
Dried |
References: Proper name: USDA 2018; Common names: McGuffin et al. 2000; Source materials: Mills and Bone 2005, ESCOP 2003, Blumenthal et al. 2000, Bradley 1992.
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 by age group:
Children 4-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
- Traditionally used in Herbal Medicine as an expectorant to help relieve chest complaints, such as mucous buildup (catarrhs), coughs and bronchitis (Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Bradley 1992; Felter and Lloyd 1983, Grieve 1971).
- Used in Herbal Medicine to help relieve inflammatory conditions of the gastrointestinal tract, such as gastritis in adults (ESCOP 2003; Hoffmann 2003; Bradley 1992).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
As specified below.
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
Subpopulations | Dried root/root and stolon (gram/day) | ||
---|---|---|---|
Minimum | Maximum | ||
Children1 |
4 years | 0.1 | 2.5 |
5-9 years | 0.15 | 3.75 | |
10-11 years | 0.3 | 7.5 | |
Adolescents1 |
12-14 years | 0.3 | 7.5 |
15-17 years | 0.6 | 15 | |
18 years and older | 0.6 | 15 | |
Table 2 Footnotes
|
Methods of preparation: Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
Subpopulations | Glycyrrhizin (milligram/day) | ||
---|---|---|---|
Minimum | Maximum | ||
Children1 |
4 years | 10 | 100 |
5-9 years | 15 | 150 | |
10-11 years | 30 | 300 | |
Adolescents1 |
12-14 years | 30 | 300 |
15-17 years | 60 | 600 | |
18 years and older | 60 | 600 | |
Table 2 Footnotes
|
Direction(s) for use
No statement required.
Duration(s) of Use
Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4-6 weeks (ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Bradley 1992).
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 have a liver disorder (Brinker 2010; ESCOP 2003; Hoffmann 2003; McGuffin et al. 1997; Bradley 1992).
Contraindication(s)
- Do not use this product if you have hypokalemia, high blood pressure, or a kidney or cardiovascular disorder (Brinker 2010; ESCOP 2003; Bradley 1992).
- Do not use this product if you are taking thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance (Brinker 2010; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; McGuffin et al. 1997).
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
- Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
- Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 1996.
- Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association; 1992.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2018 September 28]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
- Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
- Grieve M. A Modern Herbal, Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
- Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
- JC 2018: Justice Canada. 2018. Food and Drug Regulations. (C.01.021) [online]. Ottawa (ON): Justice Canada. [Accessed 2018 September 28] Available from: http://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-95.html#docCont
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
- McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
- Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
- Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
- USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Glycyrrhiza glabra L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 September 28]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=17820
References Reviewed
- Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.