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Dexsol 2mg/5ml Oral Solution (2012)

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 450mg/5ml

Garden mint flavour (containing 0.61mg/5ml propylene glycol)

Liquid maltitol 1375mg/5ml

Liquid sorbitol 700mg/5ml

For a full list of excipients, see section 6.1

List of excipients

Benzoic acid
Propylene glycol
Citric acid monohydrate
Liquid maltitol
Garden mint flavour (containing isopropanol and propylene glycol)
Liquid sorbitol non-crystallising
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
Authorization dates

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

Date of first authorisation: 08th March 2005

Marketing authorization number:

PL 00427/0137