A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdose and cause liver damage.

GUAIFENESIN

Guaifenesin is rapidly absorbed after oral administration. It is rapidly metabolised by oxidation to β-(2 methoxy-phenoxy)lactic acid, which is excreted in the urine.

PHENYLEPHRINE HYDROCHLORIDE

Phenylephrine hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber additional to that already covered in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients
Sucrose

Citric acid

Tartaric acid

Sodium citrate

Acesulfame potassium E950

Aspartame E951

Powdered menthol flavour

Lemon flavour

Quinoline yellow E104

6.2 Incompatibilities
None known.

6.3 Shelf life
24 months in Low density polyethylene 30 gm-2/aluminium foil 15 micron/low density polyethylene 12 gm-2/paper 40 gm-2 (outer layer).

24 months in 'Surlyn' 25 gm-2 (product contact layer)/aluminium foil 12 microns/low density polyethylene 12 gm-2 /bleached paper 40 gm-2 (outer layer).

6.4 Special precautions for storage
Do not store above 25°C.

6.5 Nature and contents of container
Pack sizes of five and ten sachets are available.

The sachet laminate comprises either:

Low density polyethylene 30 gm-2/aluminium foil 15 micron/low density polyethylene 12 gm-2/paper 40 gm-2 (outer layer).

or

'Surlyn' 25 gm-2 (product contact layer)/aluminium foil 12 microns/low density polyethylene 12 gm-2 /bleached paper 40 gm-2 (outer layer).

6.6 Special precautions for disposal and other handling
None.

7. Marketing authorisation holder
Wrafton Laboratories Limited (T/A Perrigo)

Braunton

Devon

EX33 2DL

8. Marketing authorisation number(s)
PL 12063/0104.

9. Date of first authorisation/renewal of the authorisation
17/06/2010

10. Date of revision of the text
17/06/2010