tion.
Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant.
5.2 Pharmacokinetic properties
Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/kg bodyweight.
Guaifenesin is readily absorbed from the gastrointestinal tract. It is rapidly metabolised and excreted in the urine.
5.3 Preclinical safety data
Not applicable.
6. Pharmaceutical particulars
6.1 List of excipients
Liquid sugar
Hydroxyethylcellulose
Glycerin
Flav F menthol E43525
Acesulfame K
Potassium sorbate
Citric acid monohydrate
Sodium citrate
Food flavour 511630E
Blackcurrant flavour 17407107
Strawberry 500244E
Patent Blue V
Carmoisine edicol
Purified water
6.2 Incompatibilities
None stated
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Pack sizes: 120ml
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
Trading as: BCM
8. Marketing authorisation number(s)
PL 00014/0555
9. Date of first authorisation/renewal of the authorisation
Not applicable
10. Date of revision of the text
15 September 2015