Special warning on the labelling of pain relievers

08 April 2011, Updated 11 April 2012

The Danish Medicines Agency requires that a special warning is placed on the labelling of large packages of medicines that contain the active substances paracetamol (e.g. Kodipar®, Pamol®, Panodil®, Paratabs® and Pinex®) and acetylsalicylic acid (e.g. Aspirin®, Codyl®, Idotyl®, Kodimagnyl "DAK", Magnyl "DAK" and Treo®). In this context "large packages" means 30 items (tablets, pills, etc.) and more.

The warning is placed in a red box and alerts parents, etc. to read the warning in the package leaflet and to store the medicine in a safe place through a wording in Danish: "Børn eller unge i hjemmet? Læs advarslen og vær omhyggelig med, hvordan du opbevarer denne medicin".

Warning label for pain-relieving medicines - Children or teenagers at home

The warning must be placed on the package and in the package leaflet

The large packages of pain relievers containing paracetamol and acetylsalicylic acid must bear the red box warning on both the outer packaging and in the package leaflet.

In the factbox to the right, we have placed an ESP file, which graphic designers can use to facilitate their work with the labelling.

The warning is intended to reduce the number of suicide attempts

The red box warning on label and package leaflet has been statutory since 1 October 2004 in Denmark, and it is intended to help reduce the number of suicide attempts with mild pain relievers.

The warning is to catch the attention of parents and grand parents, because most of the young who attempt suicide do so impulsively with medicines contained in the medicine cabinet.