The government noted that the use of such combinations could pose risks to children below four years of age and that safer alternatives were available, the ministry said.— DC Image

NEW DELHI: The Centre has mandated that all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride carry a clear warning that the medicines should not be used in children below four years of age.

The health ministry said the latest notification extends the requirement to all formulations containing the two ingredients. Earlier, the government had imposed the same age-specific warning on certain FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride.

The decision was taken following recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB).

The government noted that the use of such combinations could pose risks to children below four years of age and that safer alternatives were available, the ministry said.

Manufacturers have been directed to prominently display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on product labels, package inserts and promotional literature relating to the formulations.

The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and takes effect from the date of its publication in the Official Gazette.

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