The government has restricted the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age, mandating a clear warning against their use in this age group.
The move is aimed at safeguarding the health and safety of young children. Manufacturers have been directed to prominently display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on product labels, package inserts and promotional literature.
Earlier, through a notification dated April 15, 2025 [S.O. 1717(E)], the government had imposed similar restrictions on certain FDCs containing the two ingredients. The latest notification extends the age-specific warning requirement to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB). The government noted that the use of these combinations may pose risks to children below four years of age and that safer alternatives are available.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and will come into effect from the date of its publication in the Official Gazette.
