India Expands Under-Four Warning to All Chlorpheniramine–Phenylephrine Drug Combinations

India's Health Ministry has required every fixed-dose formulation containing chlorpheniramine maleate and phenylephrine hydrochloride to warn that it must not be used in children younger than four. The warning must appear on labels, package inserts and promotional literature. The notification, published in the Gazette on August 21, followed the Drugs Technical Advisory Board's February 16 recommendation.