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The Ministry of Health and Family Welfare notified on 22 August 2026 restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a label warning that they must not be used in children below four years of age. The notification, issued under Section 26A of the Drugs and Cosmetics Act, 1940, extends an earlier April 2025 restriction on select formulations to all such combinations, following recommendations of an Expert Committee and the Drugs Technical Advisory Board that flagged risks to young children and the availability of safer alternatives.