DEXSOL Oral solution

Product name and form

Dexsol 2mg/5ml Oral Solution.

Pharmaceutical Form

Oral Solution.

A colourless to faint yellow solution with odour of mint.

Qualitative and quantitative composition

Dexamethasone 2mg/5ml (as dexamethasone sodium phosphate).

Excipients:

Propylene glycol (E1520) – 450.6mg/5ml
Liquid maltitol (E965) - 1375mg/5ml
Sorbitol, liquid (non-crystallising) (E420) - 700mg/5ml
Benzoic acid (E210) - 5mg/5ml

For the full list of excipients, see section 6.1.

List of Excipients

Benzoic acid (E420)
Propylene glycol (E1520)
Citric acid monohydrate
Liquid maltitol (E965)
Garden mint flavour (containing isopropanol and propylene glycol (E1520))
Liquid sorbitol (non-crystallising) (E420)
Sodium citrate
Purified water

Pack sizes and marketing

Bottles: 75ml and 150ml in Amber (Type III) glass.

Closures: HDPE, EPE wadded, tamper evident, child resistant closure.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Marketing authorization dates and numbers

PL 00427/0137

8th March 2005

Drugs

Drug
Countries
Ireland, United Kingdom