No Cold Drug Combos for Kids Under 4

New Delhi, August 22, 2026 The government has tightened medicine safety measures for young children by restricting the manufacture, sale and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The decision is aimed at protecting children from possible health risks associated with these drug combinations. Manufacturers have now been directed to prominently carry the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on product labels, package inserts and promotional literature. The mandatory warning is intended to clearly communicate that these formulations should not be used for children under the age of four. The government had earlier imposed similar restrictions on certain combinations containing these ingredients through a notification issued on April 15, 2025 [S.O. 1717(E)]. Under the latest notification, however, the age-related warning requirement has been extended to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The move follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which highlighted the possible risks for children below four years of age and noted that safer alternatives are available. Issued under Section 26A of the Drugs and Cosmetics Act, 1940, the notification has been introduced in the interest of public health and will take effect from the date of its publication in the Official Gazette. The decision marks a stronger push towards ensuring safer medicine use and better protection for young children.