Canada Strengthens OTC Drug Labeling for Children’s Cold Medicines

All labels for OTC pediatric cough and cold medicines should say under the “Warnings” section that the product is not for use in children younger than 6 and include a statement that serious harm could occur if the product is taken with other cough and cold medicines, according to a Health Canada draft guidance. Labels also should warn consumers to keep the products out of reach of children, read the complete label and package insert, not exceed the recommended doses or use for longer than seven days, and consult a physician before combining with other natural, prescription or OTC products.
International Pharmaceutical Regulatory Monitor