The government has restricted the manufacture, sale and distribution of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which flagged potential risks associated with the use of these combinations in young children and noted the availability of safer alternatives.
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Manufacturers have been directed to prominently display a warning on product labels, package inserts and promotional materials stating: “Fixed Dose Combination shall not be used in children below four years of age.”
The restriction aims to prevent the use of these medicines in young children and promote safer treatment options.
