ects result from stimulation of adenyl cyclase activity. Pseudoephedrine also has an indirect effect by releasing noradrenaline from its storage sites.
Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant.
5.2 Pharmacokinetic properties
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has an elimination half-life of several hours.
Guaifenesin is readily absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.
5.3 Preclinical safety data
Not applicable.
6. Pharmaceutical particulars
6.1 List of excipients
Maltitol liquid
Hydroxyethyl cellulose
Glycerin
Purified water
Potassium sorbate
Acesulfame K
Sodium citrate
Citric acid monohydrate
Levomenthol
Alcohol 96%
Blackcurrant Flavour QL80001
Vanilla Flavour Mixture QL78307
6.2 Incompatibilities
None stated
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Amber PET bottle with polypropylene child resistant closure fitted with an expanded polyethylene liner.
Pack sizes: 100ml, 125ml, 150ml, 200ml
6.6 Special precautions for disposal and other handling
Not applicable
7. Marketing authorisation holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
England
ML 00014/01
8. Marketing authorisation number(s)
PL 00014/0545
9. Date of first authorisation/renewal of the authorisation
31 January 1997 / 30 January 2002
10. Date of revision of the text
31 October 2014
