The Human Medicines Regulations 2012

PART 4 U.K. Medicines containing paracetamol

14.  If the product contains paracetamol, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “Contains paracetamol”. U.K.

15.  If the product contains paracetamol the words “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. U.K.

16.  If the product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or younger, the words “Do not take anything else containing paracetamol while taking this medicine” and— U.K.

(a) if a package leaflet accompanying the product includes the words in quotation marks in paragraph 16 of Schedule 27 (package leaflets), the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well”; or

(b) if no package leaflet accompanies the product or the package leaflet does not include those words, 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”.

17.  If the product contains paracetamol and is wholly or mainly intended for children twelve years old or younger, the words “Do not give anything else containing paracetamol while giving this medicine” and— U.K.

(a) if a package leaflet accompanying the product includes the words in quotation marks in paragraph 17 of Schedule 27 (package leaflets), the words “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well”; or

(b) if no package leaflet accompanies the product or the package leaflet does not include those words, the words “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage”.

18.  If the product is required by this Part of this Schedule to show the words set out in paragraphs 14, 16 or 17, those words must appear in a prominent position. U.K.