2008-184
Advisory
Health Canada Releases Decision
on the Labeling of Cough and Cold Products for Children
December 18, 2008
For immediate release
OTTAWA – Health Canada is advising consumers of the outcome of its review of cough and cold
medicines for children under the age of 12.
Health Canada is requiring manufacturers to relabel 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 products affected are those containing any of the active ingredients
listed below that are given orally:
Table 1: Active Ingredients Affected by Health Canada’s Decision on Cough and Cold
Products for Children
Therapeutic Category
(Purpose)
Active Ingredients
Antihistamines in cough and
cold medicines
(used to treat sneezing,
runny nose)
brompheniramine maleate
chlorpheniramine maleate
clemastine hydrogen fumerate
dexbrompheniramine maleate
diphenhydramine hydrochloride
diphenylpyraline hydrochloride
doxylamine succinate
pheniramine maleate
phenyltoloxamine citrate
promethazine hydrochloride
pyrilamine maleate
triprolidine hydrochloride
Antitussives
(used to treat cough)
dextromethorphan
dextromethorphan hydrobromide
diphenhydramine hydrochloride
Expectorants (used to loosen
mucus)
guaifenesin (glyceryl guaiacolate)
Decongestants (used to treat
congestion)
ephedrine hydrochloride/sulphate
phenylephrine hydrochloride/sulphate
pseudoephedrine hydrochloride/sulphate
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