CDSCO bans anti-cold drug combination for kids aged under four
To ensure the safety of infants and young children in the country, the Central Drugs Standard Control Organization (CDSCO) has recently banned the use of anti-cold fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml in kids below 4 years of age.
With this, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked the state and UT drug controllers to direct all the manufacturers of the fixed-dose combination (FDC) of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml under their jurisdiction to add warning that FDC should not be used in children below 4 years of age on label and package insert/ promotional literature of the drug.
For more details, check out the link given below:
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