ROMAN CHAMOMILE - CHAMAEMELUM NOBILE
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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
October 30, 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 | ||
Chamaemelum nobile |
|
Chamaemelum nobile |
Flower |
Dried |
References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000; Source material: Wichtl 2004, Bradley 1992.
Route of Administration
Oral (Wichtl 2004; Bradley 1992)
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 mild digestive upset (such as dyspepsia, nausea and flatulence) (Wichtl 2004; Mills and Bone 2000; Bradley 1992; BHP 1983; Felter 1983; Ellingwood 1983).
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-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
1.8-12 grams of dried flower, per day (Wichtl 2004; Bradley 1992; BHP 1983)
Direction(s) for use
No statement required.
Duration(s) of Use
No statement required.
Risk Information
Caution(s) and warning(s)
Consult a healthcare practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Contraindication(s)
No statement required.
Known adverse reaction(s)
Stop use if hypersensitivity/allergy occurs (Brinker 2010; Mills and Bone 2000; Blumenthal et al. 1998).
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. Bournemouth (GB): British Herbal Medicine Association.
Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS, editors. 1998. Herbal Medicine: Complete Commission E Monographs. Boston (MA): Integrative Medicine Communications.
Bradley PR, editor. 1992. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
Ellingwood F. 1919. The American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications.
Felter HW. 1922. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications.
McGuffin M, Kartesz JT, Leung AY, Tucker AO. 2000. Herbs of Commerce. Silver Spring (MD): American Herbal Products Association.
Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [online database]. 2008. Anthemis nobilis (L.) All. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 August 8]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
Wichtl M, editor. 2004. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.
References Reviewed
Barnes J, Anderson LA, Phillipson JD. 2007. Herbal Medicines, 3rd edition. Grayslake (IL): Pharmaceutical Press.
Brinker F. 2008. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2009 June 24]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
Carnat A, Carnat AP, Fraisse D, Ricoux L, Lamaison JL. 2004. The aromatic and polyphenolic composition of Roman camomile tea. Fitoterapia 75(1):32-38.
Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. Amsterdam (NL): Elsevier.