Title: Government Restricts Chlorpheniramine-Phenylephrine FDCs for Children Below 4
New Delhi, August 22, 2026: The government has restricted the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age.
Drug manufacturers have been directed to prominently display a clear warning on product labels, package inserts and promotional literature stating: “Fixed Dose Combination shall not be used in children below four years of age.”
The move is aimed at protecting the health and safety of young children. The government noted that the use of these combinations may pose potential risks to children below four years of age, while safer alternatives are available for this age group.
Earlier, through a notification dated April 15, 2025 [S.O. 1717(E)], the government had imposed similar restrictions on certain FDCs containing the two ingredients. The latest notification now extends the age-specific warning requirement to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
The government has issued the notification under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health. The order will come into effect from the date of its publication in the Official Gazette.
The move is expected to strengthen safeguards around the use of combination medicines in young children and ensure that parents, caregivers and healthcare professionals are clearly informed about the age-specific restriction.
