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Govt bans anti-cold fixed drug combination for under-four children New Delhi

The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combination in children below four years of age. Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked the drug regulators of all states and Union territories to instruct the manufacturers of fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml to insert warning that FDC should not be used in children below 4 years of age on label and package insert/promotional literature of the drug.

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