Notice: To Market Authorization Holders: Health Canada's Decision on Labelling of Certain Paediatric (0 to under 12 years) Nonprescription Cough and Cold Products in Canada

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December 18, 2008

Contact: Bureau of Gastroenterology Infection and Viral Diseases (BGIVD)

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Notice

Our file number: 08-131053-434

To Market Authorization Holders: Health Canada's Decision on Labelling of Certain Paediatric (0 to under 12 years) Nonprescription Cough and Cold Products in Canada

This Notice provides information on Health Canada's decision related to the labelling of certain nonprescription cough and cold products that are regulated pursuant to Division 1 of the Food and Drug Regulations (FDR).

The medicinal/active ingredients included in the scope of this Notice are found in orally administered nonprescription cough and cold products and belong to the following therapeutic categories:

• 1^st generation antihistamines: brompheniramine maleate, chlorpheniramine maleate, dexbrompheniramine maleate, diphenhydramine hydrochloride, diphenylpyraline hydrochloride, doxylamine succinate, pheniramine maleate, phenyltoloxamine citrate, promethazine hydrochloride, pyrilamine maleate, triprolidine hydrochloride, and clemastine hydrogen fumarate;
• Antitussives: dextromethorphan, dextromethorphan hydrobromide, and diphenhydramine hydrochloride;
• Expectorants: guaifenesin (glyceryl guaiacolate); and
• Decongestants: ephedrine hydrochloride/sulfate, phenylephrine hydrochloride/sulphate, and pseudoephedrine hydrochloride/sulphate.

Nonprescription cough and cold products that are administered by routes other than oral are outside the scope of this Notice.

Aside from the ingredients, ephedrine and pseudoephedrine, which are now classified as natural health products, medicinal products or ingredients that are subject solely to the relevant sections of the Natural Health Products (NHP) Regulations are not affected by this decision.

1. Decision

By Fall 2009, the labelling of marketed orally administered paediatric nonprescription cough and cold products belonging to the therapeutic categories listed above are to include a statement to the effect of: "Do not use in children under 6 years of age." In addition, these products are also to have: (1) Enhanced labelling; (2) Child resistant packaging; and (3) The inclusion of dosing devices for all liquid formulations.

This decision for enhanced labelling and packaging is reflected in the draft Nonprescription Cough and Cold Labelling Standard. This labelling standard also identifies additional aspects that are being published for consultation, such as the permitted ingredients, doses, indications for use, font size, directions for use and ingredient-specific warning statements that will be required to appear on the product labels.

2. Enhanced Labelling and Packaging Requirements

By Fall, 2009, the outer and inner labels for all the products will be required to carry advisory information and directions for use such as:

• Do not use this cough and cold product in children under 6 years of age.
• Keep out of reach and sight of children.
• Do not exceed the single and maximum daily dose and duration of use recommended. Higher doses may result in serious harm.
• Do not use for longer than 7 days.
• Do not give with any other cough and cold medications since serious harm may occur.
• To temporarily relieve the symptoms of the common cold.
• For liquid formulations the following statement should be included with the directions of use: "Use only the measuring device provided."
• Read the complete label [and package insert if applicable] prior to use and follow all label instructions.
• Consult a healthcare practitioner prior to combining with other medications, including natural health products, prescription drugs or nonprescription drugs.

All of the following warnings may appear on an insert or inner panels if it can be demonstrated that space is limited on the packaging. Note that the packaging must carry clear instructions to access the insert or inner panels:

• Consult a healthcare practitioner if symptoms worsen, last for more than a week or are accompanied by a high fever (>38° C) or the production of thick yellow/green phlegm.
• Do not use if the child is allergic to any of the ingredients.
• Discontinue use if allergic reactions such as wheezing, rash or itching develop.
• Side effects reported with the use of cough and cold medications include: convulsions, drowsiness, hallucinations, allergic reaction, breathing difficulties, rapid heart rate.
• Talk to your healthcare practitioner about the proper use of this product and for information about the ingredients; and
• Emergency Management of Overdose: If poisoning occurs, call a Poison Control Centre or doctor immediately, even if you do not notice any signs or symptoms.

3. Next Steps

Market authorization holders are strongly encouraged to effect any necessary labelling changes as soon as possible. Health Canada will continue to monitor these products. By the Fall of 2009, Health Canada will be prepared to take appropriate regulatory measures, if circumstances warrant, to deal with any products that remain on the market without appropriate labelling. As of that date, orally administered nonprescription cough and cold products containing the ingredients listed above with dosing information only for children under 6 years (e.g. label has dosing for children under 6 years) are to be removed from the Canadian market.

In the interim, it is recognized that there will be products on the market that will not have the new enhanced labelling and packaging. Therefore, the appropriate use of these products will be communicated through a public advisory and an outreach/education strategy (see below).

Current market authorization holders for orally administered paediatric nonprescription cough and cold products belonging to the therapeutic categories listed above are to notify Health Canada's Submission Information and Policy Division (SIPD) within the Therapeutic Products Directorate as soon as they have met the new labelling and packaging requirements for their products by submitting a Post-authorization Division 1 Change for assessment that includes the following:

1. A signed and dated covering letter on company letterhead that includes a:

• Summary of the change(s);
• Listing of all drug products, including the Drug Identification Number(s) [DIN(s)], which are affected by the change(s); and
• Reference to the control number for the original DIN Application and any subsequent submissions.

2. A copy of all current and proposed revised labelling with highlighted changes; and

3. The completed and signed documents:

• Drug Submission Application Form (HC/SC 3011) for each product in question;
• A signed and dated Paediatric Cough and Cold Attestation Form; and
• If applicable, a Third Party Authorization Form.

To facilitate the assessment process, Health Canada encourages sponsors to also submit the information requested in electronic format.

Guidance related to how to provide electronic data to Health Canada is included in the following notice: Release of Health Canada's Revision to "1.6 Electronic Review Document" in draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.

The contact information for SIPD is:

E-mail: sipd-submissions@hc-sc.gc.ca
Telephone: (613) 946-6431
Fax: (613) 941-0825

Only those changes outlined in this Notice will be eligible for the Post-authorization Division 1 Change process.  Post-authorization Division 1 Changes which are compliant with the recommendations in the Paediatric Cough and Cold Attestation Form and which are received within 30 days after the posting of the final labelling standard will receive a priority review status. Any other changes should be submitted via a DIN application.

4. Outreach/Education Strategy

In collaboration with the relevant authorities within the health portfolio and professional health care societies, an education/outreach program has been created that:

• Informs parents, caregivers, health care practitioners and the general public of Health Canada's decision concerning nonprescription cough and cold products for children, and its implications for the use of these products;
• Provides the public with information related to other options for alleviating cough/cold symptoms for all age groups, the risk associated with using multiple products, etc.; and
• Provides information for health care practitioners to use when advising patients on the use of nonprescription cough and cold products.

As of today's date, manufacturers seeking authorization for the sale of cough and cold products in children, will be required to submit data from a pharmacokinetic study designed to provide additional dosing information for children's use, and efficacy data from paediatric protocols.

Information related to the Canadian clinical trial application process is available from the clinical trials manual, which also includes the contact information for submitting these applications to the Therapeutic Products Directorate for review.

Should you have any questions regarding the content of the Notice, please contact:

Bureau of Gastroenterology, Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Finance Building Address Locator 0202D1
101 Tunney's Pasture Driveway
Ottawa, Ontario K1A 0K9
Fax: (613) 941-1183
E-Mail: BGIVD_Enquiries@hc-sc.gc.ca