There have been no specific studies of this product, pseudoephedrine or guaifenesin in the elderly.

5.3 Preclinical safety data
The active ingredients of this product are well known constituents of medicinal products and their safety profiles are well documented. The results of pre-clinical studies do not add anything of relevance for therapeutic purposes.

6. Pharmaceutical particulars
6.1 List of excipients
Sucrose

Glycerol

Methyl Hydroxybenzoate

Propyl Hydroxybenzoate

Menthol

Ethanol 96 %v/v

Wild Cherry flavour

Ponceau 4R (E 124)

Sunset Yellow (El 10)

Purified Water

6.2 Incompatibilities
None known

6.3 Shelf life
36 months

6.4 Special precautions for storage
Do not store above 25°C. Keep container in the outer carton. Do not refrigerate.

6.5 Nature and contents of container
100 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyvinylidene chloride (PVDC) faced wad.

A spoon with a 5ml and a 2.5ml measure is supplied with this product.
6.6 Special precautions for disposal and other handling
None applicable
7. Marketing authorisation holder
McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing authorisation number(s)
PL 15513/0022
9. Date of first authorisation/renewal of the authorisation
27.09.1997
10. Date of revision of the text
30 January 2013