Health Canada
Symbol of the Government of Canada
Drugs and Health Products


Thyme - THYMUS VULGARIS

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 18, 2017

Proper name(s)

Thymus vulgaris L. (Lamiaceae) (USDA 2001)

Common name(s)

  • Thyme (McGuffin et al. 2000; Wiersema and León 1999)
  • Common thyme (McGuffin et al. 2000; Wiersema and León 1999)
  • Garden thyme (McGuffin et al. 2000; Wiersema and León 1999)

Source material(s)

Leaf and/or flowering top (Hoffmann 2003; Blumenthal et al. 2000; WHO 1999)

Route(s) of administration

Oral (Mills and Bone 2005; Blumenthal et al. 2000)

Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g., gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

  • Traditionally used in Herbal Medicine as an expectorant to help relieve the symptoms of bronchitis and catarrhs of the upper respiratory tract (anti-catarrh) (EMEA 2007; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003).
  • Traditionally used in Herbal Medicine to help relieve coughs (spasmolytic) (EMEA 2007; Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000).
  • Traditionally used in Herbal Medicine to help relieve flatulent dyspepsia and colic (carminative) (Bradley 2006; Mills and Bone 2005; Hoffmann 2003).

Dose(s)

Subpopulation:

Adults, adolescents, and children ≥ 1 year (EMEA 2007; ESCOP 2003)

Quantity:

Preparations equivalent to 1-8.4 g dried leaf and flowering top, per day (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000)

Note: See Appendix 1 for examples of appropriate dosage preparations, frequencies of use and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement required.

Risk information

Caution(s) and warning(s)

  • Consult a health care practitioner if symptoms persist or worsen.
  • Consult a health care practitioner prior to use if you are pregnant.

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.

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.
  • The medicinal ingredient may comply with the specifications outlined in the Thyme Monographs published in the European or British Pharmacopoeias.

References cited

  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • 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. 2nd edition. New York (NY): McGraw-Hill Publishing, Incorporated; 2001.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
  • EMEA 2007. European Medicines Agency. Community Monograph on Thymus vulgaris L. and Thymus zygis L., Herba. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 31 October 2007. [Accessed 2008-01-08]. Available from: Next link will take you to another Web site http://www.emea.europa.eu/pdfs/human/hmpc/thymi_herba/23411306enfin.pdf
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web site Formulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • 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.
  • Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • 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.
  • USDA 2001: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Thymus vulgaris L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-11]. Available from: Next link will take you to another Web site http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CHE): World Health Organization; 1999.
  • Wiersema J, Léon B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.

References reviewed

  • Basch E, Ulbricht C, Hammerness P, Bevins A, Sollars D. Thyme (Thymus vulgaris L.), thymol. Journal of Herbal Pharmacotherapy 2004;4(1):49-67.
  • Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Brinker F. The Toxicity of Botanical Medicines. Sandy (OR): Eclectic Medical Publications; 2000.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association.
  • Gruenwald J, Graubaum HJ, Busch R. Evaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial. Arzneimittel-Forschung 2006;56(8):574-581.
  • Gruenwald J, Graubaum HJ, Busch R. Efficacy and tolerability of a fixed combination of thyme and primrose root in patients with acute bronchitis. A double-blind, randomized, placebo-controlled clinical trial. Arzneimittel-Forschung 2005;55(11):669-676.
  • Kemmerich B, Eberhardt R, Stammer H. Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittel-Forschung 2006;56(9):652-660.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
  • Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
  • Schilcher, H. Phytotherapy in Paediatrics. Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.

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

Adults, adolescents, and children ≥ 1 year:

Infusion:

1-2 g dried leaf and flowering top, several times per day (ESCOP 2003)

Fluidextract:

1-2 g dried equivalent, several times per day (ESCOP 2003)

Adolescents, and children 4-12 years:

Tincture:

1-2 g dried equivalent per day, divided into 3-5 single doses
(1:2-2.5, 90% ethanol, 2.5-4 ml) (EMEA 2007)

Adults:

Dried leaf and flowering top:
1-2 g, 3 times per day (Bradley 2006)

Infusion:

  • 1-2 g dried leaf and flowering top, 3 times per day (Bradley 2006)
  • 2.8 g dried leaf and flowering top, 3 times per day (Hoffmann 2003)
  • 1-2 g of dried leaf, as needed (Blumenthal et al. 2000)
  • Directions for use
  • Pour 250 ml (1 cup) of boiling water on dried leaf and flowering top and steep for 10 minutes (Hoffmann 2003; Blumenthal et al. 2000).
  • 1.4 g = 1 tsp (Hoffmann 2003)

Fluidextract:

  • 1-2 g dried equivalent, several times per day
    (1:1, 1-2 ml) (ESCOP 2003)
  • 1-2 g dried equivalent, 1-3 times per day
    (1:1, 1-2 ml) (Blumenthal et al. 2000)

Tincture

  • 1-2 g dried equivalent, 3 times per day (Bradley 2006)
  • 1.2-3.6 g dried equivalent, per day
    (1:5, 6-18 ml) (Mills and Bone 2005)
  • 1-3 g dried equivalent, per day
    (1:2, 2-6 ml) (Mills and Bone 2005)
  • 0.4-1.2 g dried equivalent, 3 times per day
    (1:5, 45% alcohol, 2-4 ml) (Hoffmann 2003)