Warning mandated for two-drug cold combinations used in young children

Correct answer: B

The Union Government restricted the manufacture, sale and distribution of all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride unless they carry a clear warning that the medicine must not be used in children below four years of age. The decision followed recommendations of an Expert Committee and the Drugs Technical Advisory Board, which considered potential risks and the availability of safer alternatives. The warning must appear on the label, package insert and promotional literature. The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, and became effective from publication in the Official Gazette. For exams, focus on the two ingredients, the below-four age restriction, DTAB and Section 26A.