Health and Social Services
Cough and Cold Medicine Advisory
Health Canada will now require manufacturers of cold and cough medications to relabel their over-the-counter cough and cold medicines that have dosing information for children to indicate that these medicines should not be used in children under 6.
The relabelling of these medicines will be completed by fall 2009, in time for the next cough and cold season. During the current cough and cold season, medicineswill remain on store shelves and in homes with the current labelling, which could include dosing information for children under 6, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products. These medicines can still be used in children 6 and older, and adults.
This decision is the result of a Health Canada review of these medicines, including the input of a Scientific Advisory Panel convened in March 2008. Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children. In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6. The rare but serious potential side-effects include convulsions, increased heart rate, decreased level of consciousness, abnormal heart rhythms and hallucinations. The Scientific Advisory Panel’s conclusions and details of the new Health Canada recommendations are posted on the Health Canada Web site.
Based on a preliminary review, Health Canada at that time recommended not using over-the-counter cough and cold medicines in children under 2 years of age, unless instructed to do so by a health care practitioner. The current decision expands on those preliminary recommendations.
Until the relabelling of these products is completed, Health Canada advises parents and caregivers to follow these important guidelines:
- Do not use these over-the-counter cough and cold medicines in children under 6 years of age.
- With children older than 6, always follow all the instructions carefully, which includes the dosing and length-of-use directions, and use the dosing device if one is included.
- If you are concerned about the child’s health (such as if symptoms worsen, last for more than a week, or are accompanied by a fever higher than 38 C or the production of thick phlegm), consult a health care practitioner for a medical evaluation.
For more information about Health Canada’s decision and the use of cough and cold products in children, consult the Health Canada ( www.healthcanada.gc.ca/coughandcold ) Web site or call toll free at 1-866-558-2946.
For advice on how to properly dispose of medications, see the “It’s Your Health” article entitled The Proper Use and Disposal of Medication ( http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php ).
For more information on the safe use of medicines, see the “It’s Your Health” article entitled Safe Use of Medicine (http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/safe-secure-eng.php).
- Do not give children medications labelled only for adults.
- Do not give more than one kind of cough and cold medicine to a child. Cough and cold medications often contain multiple ingredients. Combining products with the same ingredient(s) could cause an overdose that may result in harm to a child.
- Talk to your health care practitioner (doctor, pharmacist, nurse, etc.) if you have questions about the proper use of over-the counter cough and cold medicines.
- The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity.
- For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child’s condition worsens.
