Paracetamol: Overdoses
(asked on 2nd January 2026) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the prevalence of accidental paracetamol overdose arising from the use of multiple doses of different cold and flu products.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department with responsibility for ensuring medicines meet appropriate standards of quality, efficacy, and safety. The MHRA recently reviewed the safety of paracetamol and sought advice from the Commission on Human Medicines (CHM) on 27 September 2024 on the potential risk mitigation measures to address the risk of self-harm. CHM recommended that actions need to be educational and legislative to address excessive sales and reduce potential for harm, although supportive of genuine patients.
The MHRA has recently updated voluntary Best Practice Guidance on the general sale of medicines for pain, to further highlight the risks of overdose. The update was undertaken in collaboration with retailers, stakeholders and healthcare professionals, and the updated guidance is avaiable at the following link:
Most retailers adhere to the guidelines on not promoting multiple purchases and have introduced in store measures such as till bars that restrict sales to a maximum of two packs across a range of products containing aspirin, paracetamol, or ibuprofen.
The use of paracetamol and accidental overdose is a safety concern, especially in relation to the many trade names of non-prescription and prescription medicines containing paracetamol. Therefore, the Human Medicines Regulations 2012 contain a number of conditions for the presentation of these medicines to highlight the presence of paracetamol.
Schedule 25, Part 4 of the Human Medicines Regulations sets out statutory labelling requirements for paracetamol medicines to highlight the presence of paracetamol in that product. Paragraph 14 states that, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “contains paracetamol” should be displayed. Paragraph 15 states that the labelling must highlight paracetamol on the front face of the carton or label and should also contain the warning: “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”.
Statutory warnings are also in place to warn of liver damage with overdose including the words “Do not take anything else containing paracetamol while taking this medicine” and “Talk to a doctor at once if you take too much of this medicine, even if you feel well” in the patient information leaflet. If the product does not contain a leaflet, then the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage” should be displayed on the label.
For those medicines containing paracetamol which are prescribed to a patient, the statutory warnings should be added to the prescribing label which is applied to the box by the pharmacist. These are highlighted in the British National Formulary, with further information available at the following link: