Government restricts common cold medicine combinations for children below four
The government has restricted all fixed dose combinations containing chlorpheniramine and phenylephrine for children below four, requiring a prominent warning on labels and promotional material.
The formulations must now carry a clear warning stating that they shall not be used in children below four years of age.
NEW DELHI: The government has restricted the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride for use in children below four years of age.
The formulations must now carry a clear warning stating that they shall not be used in children below four years of age. The restriction extends an earlier government order issued in April 2025 that applied the same age-specific warning to certain FDCs containing the two ingredients.
The latest decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said the combinations may pose risks to children below four years and that safer alternatives are available.
Manufacturers have been directed to display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on the product label, package insert and promotional literature associated with the formulations.
The restriction has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and takes effect from the date of publication of the notification in the Official Gazette.
The government said the latest notification extends the requirement to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, rather than only specified combinations covered by the earlier notification.
