India, Aug. 22 -- The government has imposed restrictions on the manufacturing, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The Health Ministry said the move is aimed at protecting young children from potential risks associated with these formulations.

Manufacturers have been directed to prominently display the warning, "Fixed Dose Combination shall not be used in children below four years of age," on medicine labels, package inserts and promotional literature. The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect from its publication in the Official Gazette.

The de...