Children under 2 years old should not be given over-the-counter cough and cold medicines because they are too dangerous for that age group.
Deaths, convulsions and rapid heart rates have been reported in rare cases in children younger than 2, the FDA has informed.
"We strongly recommend that over-the-counter cough and cold products should not be used in infants and young children under 2 years of age because serious and potentially life-threatening side effects can occur," Dr. Charles Ganley, head of the FDA office that reviews nonprescription drugs, told reporters.
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