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Drugs and Health Products

Monograph: Chamomile, Roman

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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: Text in parentheses is additional optional information which can be included on the PLA 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.

Date: 2009-08-05

NHPID Name

Chamaemelum nobile (USDA 2008)

Proper Name(s)

Common Name(s)

Roman chamomile ( USDA 2008 , McGuffin et al. 2000 )

Source Material

Flower ( Wichtl 2004 , Bradley 1992 )

Route Of Administration

Oral

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:

(Traditionally) used in Herbal Medicine to help relieve mild digestive disturbances (such as dyspepsia, nausea, flatulence)  (Wichtl 2004, Mills and Bone 2000, Bradley 1992, BHP 1983, Ellingwood 1983[1919], Felter 1983[1922])

Dose(s)

Adults:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 1.8 - 12 Grams per day, dried flowers

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

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.

Contraindication(s):
Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family  (Brinker 2001, Mills and Bone 2000, Blumenthal et al. 1998)

Known Adverse Reaction(s):
Hypersensitivity (e.g. allergy) has been known to occur; in which case, discontinue use  (Brinker 2001, Mills and Bone 2000, Blumenthal et al. 1998)

Non-medicinal ingredients

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

Specifications

  • 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 'Chamomile Flowers' monograph of the British Pharmacopoeia or the 'Chamomile Flower, Roman' monograph of the European Pharmacopoeia.

References cited

  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.

References reviewed

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. 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. St. Louis (MO): Elsevier Churchill Livingstone.

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

Dried flower:

  • 1.5-3g, 3 times per day (Bradley 1992)
  • 1-4g, 3 times per day (BHP 1983)

Infusion:

  • 2-3g dried flower (Wichtl 2004)
  • 1.5-3g dried flower, three times daily (Bradley 1992)
  • Directions for use: Pour boiling water over the finely cut dried flower. Steep for 10 min and then strain (Wichtl 2004).

Fluid extract:

  • 1.5-3g dried equivalent, 3 times per day (1:1, 70% ethanol, 1.5-3 ml) (Bradley 1992)
  • 1-4g dried equivalent, three times per day (1:1, 70% ethanol, 1-4 ml) (BHP 1983)

Tincture:

0.6-1g dried equivalent, three times per day (1:5, 1-5 ml) (Bradley 1992)