The Drugs Controller General of India (DCGI) has directed manufacturers of common cold drug fixed dose combination (FDC) of chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops to carry a warning to not use the combination in children below the age of four years.
In its communication dated December 18, the DCGI said the decision comes following a recommendation by the Subject Expert Committee (SEC). The drug makers are now supposed to put the new warning on the label, package insert and promotional literature.
While chlorpheniramine maleate functions as an anti-allergic, phenylephrine acts as a decongestant narrowing small blood vessels to provide relief from nasal congestion or stuffiness.
