India Expands Warning for Chlorpheniramine Maleate-Phenylephrine Fixed-Dose Combinations

India's Ministry of Health and Family Welfare has expanded warning-label requirements for all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. Manufacturers are now required to display a warning stating that these FDCs "shall not be used in children below four years of age." This regulatory action, effective August 19, 2026, aims to enhance patient safety, particularly for young children.