Children 6-11 years

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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.


Compliance with Precursor Control Regulations:

The Precursor Control Regulations (PCR) (JC 2018a) 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 pseudoephedrine 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:


September 25, 2018

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s)
Source material(s)
Common name(s)
  • (1S,2S)-2-Methylamino-1-phenylpropan-1-ol
  • (alphaS)-alpha-[(1S)-1-(Methylamino)ethyl]benzenemethanol
  • d-psi-Ephedrine


  • Pseudoephedrine
  • Pseudoephedrine hydrochloride
  • Pseudoephedrine sulfate

References: Proper names: NLM 2018, O'Neil et al. 2018; Common name: NLM 2018, O'Neil et al. 2018; Source materials: NLM 2018, O'Neil et al. 2018.

Route of Administration


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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)



Children 6 to 11 years


30-120 milligrams pseudoephedrine per day; Not to exceed 30 milligrams per single dose (Simons et al. 1996; Dickerson et al. 1978).

Direction(s) for use

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days (HC 2009; US FDA 2004).

Risk Information

Caution(s) and warning(s)


No statement required.

Known adverse reaction(s)

Stop use if allergic reactions, breathing difficulties, convulsions, drowsiness, hallucinations or rapid heart rate occur (Blumenthal et al. 2000; Dickerson et al. 1978).

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

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


References Cited

References Reviewed