New Delhi, April 16 -- The central government has mandated strict labelling requirements for manufacture, sale and distribution of the fixed-dose combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride, prohibiting its use for children under four years of age.

The combination medicine is used to ease symptoms of common cold and allergies, and may cause dizziness and dryness of the mouth, among other side effects.

In a notification issued by the Union ministry of health and family Welfare on 15 April, the government has directed that all formulations of this fixed-dose combination must now carry a clear warning label stating: "Fixed dose combinations shall not be used in children below four years of age."

It said this wa...