The government has restricted the manufacture, sale and distribution of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.
The decision has been taken to protect young children from potential health risks associated with these drug combinations. Authorities have advised that such medicines should not be used for children in this age group.
Drug manufacturers have been directed to display a clear warning on the labels, package inserts and promotional material stating that the fixed-dose combination should not be used in children below four years of age.
The restriction follows recommendations from an expert committee and the Drugs Technical Advisory Board. The government has said the measure is being implemented in the interest of public health.
The latest decision expands an earlier restriction issued in 2025 covering certain formulations containing the two ingredients. The new measure applies to all such combinations intended for use in children below four years.
