Drugs: Safety
(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 steps his Department is taking to raise public awareness of the risks of taking multiple doses of different over-the-counter medicines which contain the same active ingredient.
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 Human Medicines Regulations 2012 lays out the conditions of the licencing and marketing of a medicine. This includes the information which must be provided with the medicinal product.
Schedule 24 specifies that the outer and immediate packaging of medicinal products must display the name of the medicinal product, the strength and pharmaceutical form, and when the product contains more than three active substances, the common name for the active substances. In addition, regulation 259 states that packaging or outer label should present the name in braille for the blind or partially sighted. In addition, schedule 24 states that the labelling should display the contents, for instance the number of tablets, where to store, expiry date, the manufacturers name, and any special precautions relating to the product.
The MHRA has recently updated voluntary Best Practice Guidance on the general sale of medicines for pain, to further highlight the risks of overdose, to address public concerns and recognise current sales techniques. Links are also provided to patient support groups, including Papyrus for young people. 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 aim of these voluntary measures is to balance the need of people for access to pain relief medicines against the dangers for vulnerable individuals and to reduce the opportunity for customers to purchase on impulse excessive quantities of any single analgesic, like paracetamol, aspirin, or ibuprofen.
Paracetamol and ibuprofen are well-known medicines for pain, which when taken as recommended, have well-established safety profiles. The vast majority of patients use these medicines responsibly as effective pain-relievers.
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 in a medicine.
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”, which must appear adjacent to either the directions for use or the recommended dosage.
Further to this, if the product contains a leaflet, paragraph 16 states that if the product contains paracetamol, unless the product is wholly or mainly intended for children aged 12 years old or younger, the words “Do not take anything else containing paracetamol while taking this medicine” and the warning “Talk to a doctor at once if you take too much of this medicine, even if you feel well” must be included. 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.
Schedule 8 of the regulations also set out the material which must accompany any application for the marketing of a medicine. The Summary of Product Characteristics (SmPC) as referenced in part 2, for healthcare professionals, provides a summary of the clinical particulars in the use of a medicine, including the recommended maximum daily dose. In addition, particulars in reference to overdose are provided. This includes the potential dose over which liver damage may occur and potential risk factors which may elevate the risk of overdose, including medical history, concomitant medicines, or alcohol intake. A summary of the symptoms of overdose and management are also provided.
The market authorisation holders are obligated under the Human Medicines Regulations to continually review the safety of their medicines and to inform the MHRA of any serious adverse reactions. The MHRA continues to monitor the safety of all medicines and if necessary, will take advice from our independent experts on recommended regulatory action. The MHRA provides a list of the SmPCs and patient leaflets for all medicines at the following link:
Additional resources on product information and the treatment of overdose are available from the British National Formulary (BNF), the electronic medicines compendium, the National Poisons Information Service, and National Health Service, with further information available at the following link:
https://www.nhs.uk/medicines/paracetamol-for-adults/
The Human Medicines Regulations and the BNF highlight the information that is required in general and electronic prescriptions.