Guidance

Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines

Updated 1 July 2026

1. Purpose

The purpose of this guidance is to set out the warning statements which should appear on the label and/or in the leaflet of certain medicines. UK legislation foresees the need for certain medicines to include warningb statements on the label to enable these to be used safely and to best effect.

Previously, a small number of warning statements were included by statute and appeared in Schedule 5 to the Medicines (Marketing Authorisations etc) Regulations 1994 number 3144 [SI 1994/3144]. These applied principally to a small number of medicines available over-the-counter. Many more warning statements were added to the labelling of other medicines through the marketing authorisation rather than through a legislative provision.

As part of the consolidation of the Medicines Act and in line with the better regulation principals operated under Cabinet Office guidelines, with the exception of warning statements to be applied to all medicines containing paracetamol, warning statements will no longer appear on the face of the legislation. Amending legislation is complex and by setting out those medicines and the associated warnings in guidance flexibility can be applied by Marketing Authorisation Holders (MAH) in how these statements are implemented.

2. Status

Although having no legal force it is expected that MAHs will apply these warning statements to the labelling and/or the leaflet as appropriate. It will not be necessary to use the wordings proposed verbatim, but it should be borne in mind that many of these forms of words have already been the subject of user testing and are in use (through the British National Formulary) on dispensing labels applied in pharmacies across the UK. Care should be taken to ensure that any deviation from what is set out below does not cause confusion amongst patients.

The warning statements are divided into general and specific categories and for some medicines warnings from both sections may need to be applied.

3. General warning statements

For Pharmacy Only (P) medicines where the product would be prescription only if it contained a higher proportion of the active ingredient unless it is an antihistamine or for external use e.g. ibuprofen, codeine, paracetamol

This should be placed adjacent to the directions for use or the recommended Warning statements 0919 dosage:

Warning: Do not take more medicine than the label tells you to.

If the product is for external use only and is and embrocation, liniment, lotion, cream, liquid antiseptic or other liquid preparation or gel. Where the medicine is a Pharmacy Only (P) medicine this statement must appear on the label:

Use this medicine only on your skin.

For medicines which are available as Pharmacy Only. The letter “P” must appear in a box in which there is no other information.

For medicines which are available only on prescription. The letters “POM” must appear in a box in which there is no other information.

Controlled drugs

Medicines which fall to be considered as controlled drugs under the Misuse of Drugs Act 1971 should include the following next to the declaration of the legal status on the labelling. The letters CD in an inverted triangle.

All medicines

In line with Part 13 of the HMRs a warning that users should “keep out of the sight and reach of children” should appear on the label of all medicines.

In line with Part 13 of the HMRs, a statement encouraging patients to report adverse events which they may experience to the competent authority should appear in the patient information leaflet. In the UK the following form of words should be used.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme Website or search for the Yellow Card app in Google Play or Apple App Store.By reporting side effects you can help provide more information on the safety of this medicine.

This should appear at the end of section 4.

Medicines subject to additional monitoring

Medicines which appear on the black triangle list published on the MHRA website should include the inverted black triangle immediately after the name in the patient information leaflet followed by the wording in schedule 27 of Human Medicines Regulation 2012 (as amended).

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

The black triangle and the statements should only appear immediately after the declaration of the name of the medicine. The black triangle shall be a black inverted equilateral triangle: the triangle shall be proportional to the font size of the subsequent standardised text and in any case each side of the triangle shall have a minimum length of 5 mm.

Specific statement (alphabetical by drug substance)

ADENOSINE

Conditions for P supply

The SPC, label and leaflet should advise the patient:

• not to take the medicine for longer than 12 weeks without medical advice
• not to take more than the recommended dose

Not for children under 14 years of age.

Label warnings: * Do not take more than the label tells you to * If you do not get better within 12 weeks talk to your doctor * Do not give this medicine to children under 14 years

ALCLOMETASONE

For topical medicines available as P for over the counter supply the following statements should appear prominently on the label

If you are pregnant talk to your doctor before using.

Apply a thin layer over the affected area of your skin. Do this once or twice a day. If you need to use it for longer than 7 days, stop using and talk to your doctor.

ALOXIPRIN

If the product contains aloxiprin. These statements must be placed prominently on the packaging:

Contains an aspirin derivative

Do not give to children under 16 years of age unless your doctor tells you to.

If you do not get better talk to your doctor

If the product contains aloxiprin these statements must be included on the label where a PIL is NOT separately available.

Aspirin and aspirin derivatives can cause Reye’s syndrome when given to children. This is a very rare disease but it can be fatal. Do not give this medicine to children under 16 years of age unless your doctor tells you to.