Pseudoephedrine Children 6-11 Years

What is it used for?

• Used as a decongestant (for the common cold) [Source note 5].

• Temporarily relieves/For the temporary relief of cold/(and) flu symptoms such as nasal congestion/sinus congestion/stuffy nose/nasal stuffiness [Source note 6].

• Temporarily relieves/For the temporary relief of nasal congestion/sinus congestion/stuffy nose/nasal stuffiness (due to hay fever/allergic rhinitis/the common cold) [Source note 7].

• Nasal decongestant [Source note 8].

Note: The above usages can be combined on the product label (e.g., Nasal decongestant to temporarily relieve nasal congestion due to the common cold).

What this guide covers

• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.

• this reference cannot be combined with any other reference at Class II. Theses products may be submitted as a source review category III along with evidence to support their safety and efficacy.

• To mitigate the potential risk to the health of children, it is recommended that child resistant packaging/containers be used as described in Sections C.01.001(2) to (4), and subsection C.01.031(1) (a) (i) of the Food and Drug Regulations [Source note 1].

Compliance with Precursor Control Regulations:

The Precursor Control Regulations (PCR) [Source note 2] 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: [Source note 3]

Who does this guide cover?

Children 6 to 11 years

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Quantities

30 - 120 milligrams pseudoephedrine per day; Not to exceed 30 milligrams per single dose [Source note 9].

How is it used?

• Give a single dose every 4-6 hours, up to 4 times per day [Source note 10].

• Do not give with any other cough and cold medications since harm may occur [Source note 11].

How long is it used?

Ask a healthcare professional for use beyond 7 days [Source note 12].

Warnings and precautions

• Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away [Source note 13].

• Ask a healthcare professional if symptoms worsen or last for more than 7 days [Source note 14].

• Ask a healthcare professional if symptoms are accompanied by a high fever that lasts longer than 3 days, the production of thick yellow/green phlegm, rash or a persistent headache.

• Ask a healthcare professional before use if the child is taking any other medications including cough and cold or weight control medications or prescription drugs, or products which contain caffeine or ephedrine [Source note 15].

• Ask a healthcare professional before use if the child has asthma, diabetes, glaucoma, heart disease, high blood pressure, kidney disease, thyroid disease, or seizure disorders or any other serious medical condition [Source note 16].

When should it be avoided?

Do not use in a child who is taking a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping theMAOI drug [Source note 17].

Possible side effects

• Stop use and ask a healthcare professional if the child experiences severe headache, confusion, visual changes/changes in vision, nervousness, dizziness, sleeplessness, difficulty or pain when urinating or allergic reactions [Source note 18].

• Stop use and ask a healthcare professional if any new symptoms appear.

Storage

Must be established in accordance with the requirements described in the applicable product regulations.

All products (information for industry; not for labelling)

To be packaged in airtight container, protected from light [Source note 19].