Centre Restricts Cold Medicine Combinations for Children Below 4 Years
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The Central Government has imposed restrictions on the manufacture, sale, and distribution of all fixed-dose combination (FDC) medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The notification mandates that these medicines must not be used in children under the age of four.
The latest order expands an earlier notification issued on April 15, 2025, which had applied the same age-specific warning to certain FDCs containing these ingredients. The new notification now covers all formulations with this combination.
Why has the government issued this mandate?
The decision was taken following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said that the combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride may pose health risks to children below four years of age, prompting the stricter safety warning.
