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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Notification on Restriction of Fixed Dose Combinations of Chlorpheniramine Maleate + Phenylephrine Hydrochloride for Children

19-Aug-2026 | S.O. 4595(E)

This notification restricts the manufacture, sale, or distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating that manufacturers prominently display a warning on product labels, package inserts, and promotional literature stating: "Fixed dose combination shall not be used in children below four years of age." This is based on recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB) due to potential safety risks to young children where safer alternatives exist.

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