Paracetamol combination drugs to carry warnings

Manufacturer of paracetamol combination products will now have to print a statutory warning on the drug boxes stating ‘Taking more than the daily dose of paracetamol may cause serious liver damage or allergic reactions’.

Besides, the Drug Controller General of India (DCGI) has asked the state licensing authorities not to grant fresh licenses or renewals to products with combination of paracetamol, containing more than 325 mg per tablet or capsule.

The decision of limiting acetaminophen (paracetamol) comes in the wake of the US FDA issuing a similar note on January 13, 2011. “Manufacturers marketing combination products having more than 325 mg of paracetamol have been asked to limit the paracetamol contents to 325 mg,” Sanjay Patil, joint commissioner (drugs), FDA, Pune, said on Tuesday.

The drugs containing paracetamol as single ingredient will remain unaffected by the new order,” Patil said.