New Label Warning for FDC of Chlorpheniramine Maleate

To All State/ UTs Drugs Controllers,

Subject: To update package insert/Promotlonal Literature of FDC of Chlorphenlramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml – regarding.

The FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml was declared as rational by Prof. Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on 17.07.2015 under the 18 months policy decision.

Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulation for Infants. The matter was deliberated in Subject Expert Committee (SEC· Pulmonary) meeting held on 06.06.2023 where in. In light of the issue regarding use of the FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5 mg 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 packag Insert.

There recommendation of the SEC has been considered by this office.

ALSO READ: Drug Safety Alert PVP November 2023

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About the Author: Kiran Kumar Chemudugunta

Kiran Kumar Chemudugunta with 15 Plus years of Experience in IT Life Sciences Industry, My Expertise in Pharmacovigilance and Computer System Validation. I have worked with Multinational Companies like TechMahindra Bioclinica Cognizant Icon Clinical Research Hcl Technologies Founder of Pvchronicle, Rise Trainings & Recruiting Best

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