New Delhi, Aug. 22 -- The government imposed restrictions on the manufacture, sale and distribution of all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. It issued a clear mandate that these medicines shall not be used in children below four years of age.

Earlier, as per a notification dated April 15, 2025, the government had restricted certain fixed-dose combinations (FDCs) containing the two chemical compounds, subject to the same age-specific warning.

The latest notification extends this requirement to all formulations containing these two ingredients, news agency PTI reported.

The decision followed recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB).

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