National

Union Health Ministry Restrictions on Children’s Cold Medicines

• Statutory Notification: Issued under Section 26A of the Drugs and Cosmetics Act, 1940, expanding curbs on all Fixed-Dose Combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.
• Mandatory Warning Label: All manufacturers must prominently print a warning stating: “Fixed Dose Combination shall not be used in children below four years of age” due to risks of dosing errors, severe drowsiness, or adverse events in young children.