FDC of Chlorpheniramine + Phenylephrine with other Drugs for Children below four years
We are aware that Government of India has restricted the use of Fixed Dose Combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride in Children below Four Years vide notification SO 1717 (E) dated 15.04.2025, with immediate effect i.e. from 15.04.2025.
There are few products in the market containing one or more active ingredients in addition to Chlorpheniramine Maleate and Phenylephrine HCl, such as Paracetamol, Dextromethorphan HBr, etc. Strictly in law, the said notification will not be applicable for the FDCs containing additional ingredients.
However, in view of safety of children below four years, it is advisable to specify on label, package insert or promotional literature of such FDCs containing aforesaid ingredients and one or more additional ingredients with the mandated warning “Warning: Fixed dose combination shall not be used in Children below four years of age”.