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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Warning: FDC should not be used in children below 4 years of age on the label and package insert/Promotional Literature of the drug

18-Dec-2023 | 04-01/2022-DC (Misc.-47)

Central Drugs Standard Control Organization has issued a Public Notice to update package insert/Promotional Literature of FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCl IP 5mg drop/ml, effective from 18th December 2023. By virtue of the Public Notice, it informed all the manufacturers of FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCl IP 5mg drop/ml under to mention the warning FDC should not be used in children below 4 years of age on the label and package insert/Promotional Literature of the drug. Note: Concerns have been raised regarding the promotion of unapproved anti-cold drug formulations for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on 06.06.2023 wherein, in light of the issue regarding the use of the FDC of Chlorpheniramine Maleate |P 2mg + Phenylephrine HCL IP 5mg drop/ml was discussed before the committee. The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert. For detailed information, please refer to the attached document.

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