What happened (latest restriction on Chlorpheniramine Maleate + Phenylephrine Hydrochloride FDCs)
The Ministry of Health and Family Welfare restricted the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The restriction requires a clear age warning that these medicines shall not be used in children under four years.
Manufacturers have been directed to display the warning with the exact wording on:
labelpackage insertpromotional literature
The mandatory warning wording is: “Fixed Dose Combination shall not be used in children below four years of age”.
Background and earlier position (April 15, 2025 restriction for certain formulations)
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