Government restricts FDCs with chlorpheniramine, phenylephrine for children below 4

The Union Health Ministry has imposed restrictions on the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age.

Last year, the Government restricted certain FDCs containing the two ingredients, subject to the same age-specific warning. The latest notification extends the requirement to all formulations containing these two ingredients.

The decision follows recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB). The Government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.

Manufacturers have been directed to prominently display the warning — “Fixed Dose Combination shall not be used in children below four years of age,” on the label, package insert and promotional literature associated with these formulations.

The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette.

The Centre’s move comes amid tightened scrutiny of cough-and-cold medicines in young children. The combination of chlorpheniramine maleate, an antihistamine used to reduce symptoms such as a runny nose and sneezing, and phenylephrine hydrochloride, a decongestant intended to relieve nasal blockage, has long been used in cold and allergy preparations.

Young children are particularly vulnerable to dosing errors and adverse effects from multi-ingredient medicines. Chlorpheniramine can cause marked drowsiness or, paradoxically, excitability, while phenylephrine can affect heart rate and blood pressure. At the same time, evidence that such combinations substantially improve uncomplicated colds in children is limited.

India had already required warnings on certain formulations in 2023 and formally restricted the combination in 2025; the latest notification extends the restriction to all such FDC formulations for children below four. Internationally, countries including the US and Australia, have also adopted age restrictions or other safeguards for paediatric cough-and-cold medicines.