Chlorpheniramine-Phenylephrine Drugs Restricted for Kids Below 4

The government has restricted the manufacturing, sale and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.

The Health Ministry has directed drug manufacturers to prominently display a warning stating: “Fixed Dose Combination shall not be used in children below four years of age.” The warning must appear on medicine labels, package inserts and promotional materials.

The government said these combinations could pose health risks to young children, while safer treatment options are available.

The decision follows recommendations from an Expert Committee and the Drug Technical Advisory Board (DTAB). Earlier in June, the government had also banned the manufacture, sale and distribution of 16 FDC medicines for human use across the country.