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

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 has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical safety data
Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.

6. Pharmaceutical particulars
6.1 List of excipients
Sorbitol 70 per cent (crystallising) (E420), glycerol (E422), alcohol (96%), propylene glycol, sodium cyclamate (E952), acesulfame potassium (E950), sodium citrate (E331), xanthan gum (E415), citric acid monohydrate (E330), coughsweet flavour, sunset yellow (E110), Patent Blue V (E131), water.

6.2 Incompatibilities
None known.

6.3 Shelf life
Two years.

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

6.5 Nature and contents of container
Bottle: amber flint glass with Child Resistant Closure: polypropylene/HDPE with polyester-coated aluminium faced boxboard wad. Contains 240 ml.

6.6 Special precautions for disposal and other handling
Not applicable.

7. Marketing authorisation holder
Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS

8. Marketing authorisation number(s)
PL 00079/0381

9. Date of first authorisation/renewal of the authorisation
29 October 2003

10. Date of revision of the text
14/10/2011