Published: 16 December 2013

Changes to the Label Statements Database for codeine-containing medicines

Product sponsors
Applicants for new and changed medicines
Regulatory affairs consultants

This letter is to:


On 29 September 2012, Medsafe received a complaint from a healthcare professional about the use of “non-drowsy” on codeine-containing medicines, as drowsiness is one of the major side effects of codeine.

Medsafe investigated the complaint and reviewed available information from published literature, data from international regulators and affected sponsors. Medsafe then concluded that:

Medsafe also considered whether there was justification for a non-drowsy statement when codeine was used in medicines containing a combination of codeine and phenylephrine. Medsafe concluded there is no evidence that the addition of phenylephrine to codeine-containing cough and cold products counteracts any drowsiness that might occur.

Given the potential for codeine to cause drowsiness in certain patients, Medsafe proposes that the following statements be added to the Label Statements Database for all codeine-containing medicines (including cough and cold medicines):

Next steps

Queries about, or comments on, the proposed changes described above should be sent to:
Laurence Holding
PO Box 5013

by Monday 3 March 2014.
Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (
Yours sincerely
Sarah Reader
Manager Product Regulation