Health Canada is requiring manufacturers to relabel over-the-counter cough and cold medicines with certain active ingredients to indicate that they should not be used in children under 6.

Although cough and cold medicines have been used by children for many years, there is limited evidence supporting their effectiveness in this group. In addition, reports of misuse, overdose and very rare serious side-effects have raised concerns about the use of these medicines in children under 6.

The risk to children is only at the time of use; in other words, children who used these products in the past are not at risk from having taken them.

The relabelling of over-the-counter cough and cold medicines will be completed by fall 2009, in time for the next cough and cold season. Until then, these medicines will remain on store shelves and in homes with the current labelling. Labels 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. 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.

Treating the Symptoms of a Cold
There is no cure for the common cold, but there are other ways to help your child feel more comfortable by treating the symptoms: stuffed-up nose, cough, feeling achy and tired:

• Allow the child adequate rest and clear nasal passages;
• Ensure plenty of clear fluids (for example, water, diluted non-sweetened fruit juice, or clear soups) to prevent dehydration while keeping the throat moist; and
• Provide a comfortable environment with adequate humidity.

If symptoms do not improve within 6 to 10 days, worsen, or are accompanied by a fever higher than 38 C or by thick mucus (phlegm), consult a health care practitioner.

Next Steps
Health Canada is currently consulting to finalize the requirements for the new label for paediatric cough and cold medicines.

• Consultation on Draft Labelling Standard [1]

The relabelling of these medicines will be completed by fall 2009, in time for the next cough and cold season.

Source: Health Canada [2]