5.3 Preclinical safety data
Carcinogenicity

There is insufficient information available to determine whether guaifenesin has carcinogenic potential.

Mutagenicity

There is insufficient information available to determine whether guaifenesin has mutagenic potential.

Teratogenicity

There is insufficient information available to determine whether guaifenesin has teratogenic potential.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

6. Pharmaceutical particulars
6.1 List of excipients
Xanthan gum

Sodium chloride

Saccharin sodium

Ammonium glycyrrhizate

Sodium benzoate (E211)

Citric acid anhydrous

Sodium citrate

Macrogol glycerol hydroxystearate 40

Levomenthol

Raspberry flavour F2126 (includes ethanol, glucose and fructose)

Caramel (E150) (includes glucose)

Ponceau 4R (E124)

Glycerol

Macrogol 1500

Propylene glycol

Ethanol 96%

Purified water

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
3 years

In-use: 4 weeks

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

Store in the original container to protect from light

6.5 Nature and contents of container
Type III, Amber glass bottle, containing 150ml, fitted with:

A plastic child resistant cap fitted with a PET-faced wad.

A plastic dosing cup marked with a 10ml graduation may be included in this pack.

6.6 Special precautions for disposal and other handling
No special requirements.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required (these should be disposed of in line with local requirements). These measures will help to protect the environment.

7. Marketing authorisation holder
McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing authorisation number(s)
PL 15513/0165

9. Date of first authorisation/renewal of the authorisation
5 May 2010

10. Date of revision of the text
30 June 2015