SCHEDULES

Regulation 221

SCHEDULE 15U.K.Requirements for specific products subject to general sale

1.  A medicinal product that contains aloxiprin, aspirin or paracetamol (or, where appropriate, any combination of those substances) and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—U.K.

Column 1Column 2

Effervescent tablets—

(a) that do not contain aspirin, or

(b) that do not contain more than 325 milligrams of aspirin per tablet.

30 tablets

Effervescent tablets—

(a) that contain more than 325 milligrams of aspirin per tablet, but

(b) that do not contain more than 500 milligrams per tablet.

20 tablets

Non-effervescent tablets—

(a) that are enteric-coated,

(b) that contain aspirin only, and

(c) that do not contain more than 75 milligrams per tablet.

28 tablets
Other non-effervescent tablets16 tablets
Powder or granules10 sachets
Capsules16 capsules
Liquid preparations of paracetamol intended for persons aged 12 years and over160 millilitres
Liquid preparations of paracetamol intended for persons aged less than 12 yearsIndividual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses

2.  A medicinal product that contains ibuprofen and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—U.K.

Form of productMaximum amount
Tablets16 tablets
Capsules16 capsules
Powder or granules12 sachets
Liquid preparations of ibuprofenIndividual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses