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Drugs and Health Products

Monograph: Ephedrine, L-

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COMPLIANCE WITH PRECURSOR CONTROL REGULATIONS: The Precursor Control Regulations (PCR) (JC 2010) allows Canada to fulfill its international obligations with respect to the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988, and provides a framework for the regulation of activities involving precursor chemicals which can be used in the production of illicit drugs and substances. Under the PCR, regulated chemicals are grouped into two classes: Class A and Class B. For class A precursors such as ephedrine and/or products containing them, persons wishing to be involved in activities such as importation, exportation, production, packaging, selling, and/or providing must first obtain a licence. Further information regarding compliance with the PCR, including application forms and guidance documents pertaining to the application for a Class A precursor licence, is available at:

Date: 2018-07-31


l-Ephedrine (O'Neil et al. 2012)

Proper Name(s)

Common Name(s)

Source Material

Route Of Administration


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:

Used as a decongestant/to relieve nasal congestion (due to hay fever/allergic rhinitis/allergies/sinusitis/the common cold/flu).



Dose(s): 1 Day per day

See Appendix 1 for dosage information.

Duration of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days.  (Mills and Bone 2005, US FDA 2004, Blumenthal et al. 2000)

Risk Information

Statement(s) to the effect of:

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 taking medication and/or natural health products for allergy symptoms, asthma, cough/cold or weight control.
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use, if you are taking other products containing caffeine, ephedrine, phenylpropanolamine or pseudoephedrine.
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use, if you have cardiovascular disease, diabetes, difficulty in urination due to prostate enlargement, glaucoma, thyroid problems, seizure disorders or a pre-existing psychiatric condition.
  • Keep out of the reach of children.

  • Consult a healthcare practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding.
  • Do not use this product if you are taking, or have taken monoamine oxidase inhibitors in the past two weeks.

Known Adverse Reaction(s):
Stop use , in case of restlessness, irritability, dizziness, tremor, severe headache, insomnia, loss of appetite, nausea, rapid heartbeat, shortness of breath and/or disturbance of urination.

Non-medicinal ingredients

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

Storage Conditions

Store protected from light and moisture (BP 2009, USP 32, Ph. Eur. 2007).


  • 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 following monographs: (i) Ephedrine Anhydrous, Ephedrine Hydrochloride and Ephedrine Hydrochloride, Racemic published in the European Pharmacopoeia (Ph. Eur. 2007) and (ii) Ephedrine, Ephedrine Hydrochloride and Ephedrine Sulfate published in the U.S. Pharmacopeia (USP 32).

References cited

  • Astrup, A., Buemann, B., Christensen, N. J., Toubro, S., Thorbek, G., Victor, O. J., Quaade, F. 1992. The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women. Metabolism 41(7):686-688.
  • Bensky D, Clavey S, Stoger E. Gamble A. 2004. Chinese Herbal Medicine: Materia Medica 3rd Edition. Seattle (WA): Eastland Press.
  • BHP 1983: British Herbal Medicine Association (BHMA) Scientific Committee. 1983. British Herbal Pharmacopoeia 1983. Bournemouth (GB): British Herbal Medicine Association.
  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
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  • BP 2009: British Pharmacopoeia Commission. 2009. British Pharmacopoeia, 2009, Volume 1. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, Third Edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2008. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2009 November 20]. Available from:
  • Coffey CS, Steiner D, Baker BA, Allison DB. 2004. A randomized double-blind placebo-controlled clinical trial of a product containing ephedrine, caffeine, and other ingredients from herbal sources for treatment of overweight and obesity in the absence of lifestyle treatment. International Journal of Obesity & Related Metabolic Disorders 28(11):1411-1419.
  • Dawson JK, Earnshaw SM, Graham CS. 1995. Dangerous monoamine oxidase inhibitor interactions are still occurring in the 1990s. Journal of Accident and Emergency Medicine 12:49-51.
  • Dingemanse J, Guentert T, Gieschke R, Stabl M. 1996. Modification of the cardiovascular effects of ephedrine by the reversible monoamine oxidase a-inhibitor moclobemide. Journal of Cardiovascular Pharmacology 28(6):856-861.
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  • Pickup ME, May Ca, Ssendagire R, Paterson JW. 1976. The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment. British Journal of Clinical Pharmacology 3:123-134.
  • Shekelle PG, Hardy ML, Morton SC, Maglione M, Mojica WA, Suttorp MJ, Rhodes SL, Jungvig L, Gagné J. 2003. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. Journal of the American Medical Association 289(12):1537-1545.
  • US FDA 2004: United States Food and Drug Administration. Final Rules Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Final Rule [online]. Federal Register, Volume 69, Number 28, February 11, 2004, Rules and Regulations, Docket Number 1995N-0304. Rockville (MD): United States Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 November 23]. Available from:
  • USP 32: United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.
  • Williamson EM. 2003. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited.

References reviewed

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  • Burke LM. 2000. Positive Drug Tests from Supplements. Sportscience 4(3):1-5.
  • CRN 2000: Council for Responsible Nutrition. Safety Assessment and Determination of a Tolerable Upper Limit for Ephedra. [online] Mississauga (ON): Cantox Health Sciences International. [Accessed 2009 November 23]. Available from:
  • Cui J, Zhou T. 1991. Analysis of alkaloids in Chinese ephedra species by gas chromatographic methods. Phytochemical Analysis 2:116-119.
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Appendix 1: Derivation of dosage quantities for l-ephedrine

Single maximal dose of l-ephedrine: 8 mg (US FDA 2004; HC 2003).

Minimum dose per day of l-ephedrine: 8 mg (US FDA 2004; HC 2003)

Maximum dose per day of l-ephedrine: 32 mg

Obtained as follows: 24 h daily ÷ 6 h half life of l-ephedrine x 8 mg per single dosage (HC 2003; Pickup et al. 1976)


Appendix 2: Background on Monograph

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 applicant's 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.