Published: 21 June 2017


Change to Label Statement Database for OTC loratadine and desloratadine medicines

The Label Statement Database (LSD) has been updated to include an alternative sedation warning for over-the-counter (OTC) medicines containing loratadine or desloratadine. The existing and alternative statements can be found in the LSD via the following link:

OTC medicines containing loratadine or desloratadine are now required to carry one of the following warning statements on their packaging:

Existing statement: ‘Although this medicine is unlikely to affect your ability to drive or operate machinery, a few people may be impaired and care should be taken’.
Alternative statement: ‘Some people might get drowsy on this medicine. You should make sure you are not affected before doing activities that require full attention, such as driving or operating machinery’.

The wording of the alternative statement was recommended by the Medicines Adverse Reactions Committee (MARC) at the 169th MARC Meeting on 9 March 2017 following a public consultation. The consultation outcome was published on the Medsafe website on 12 May 2017.

Medsafe recognises that the wording of the statement recommended by the MARC is no more or less restrictive than the existing statement, and considers that a pragmatic response to the MARC’s recommendation would be to allow either wording.

The LSD lists the warning and advisory statements that are required on medicine and related product labels under regulations 13(1)(i) and 14(1)(f) of the Medicines Regulations 1984.

Words of a similar meaning to the statements in the database may be used and individual statements may be combined provided the intent is not changed. Unless specifically indicated, the statements do not apply to prescription medicines.

Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /