ONDANSETRON Syrup Ref.[7026] Active ingredients: Ondansetron

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Focus Pharmaceuticals Ltd, Capital House, 1<sup>st</sup> Floor, 85 King William Street, London EC4N 7BL, United Kingdom

Product name and form

Ondansetron 4mg/5ml Syrup.

Pharmaceutical Form

Syrup.

Clear strawberry flavoured liquid.

Qualitative and quantitative composition

Each 5ml contains 4mg of ondansetron as the hydrochloride dihydrate.

Excipients with known effects: Ethanol (less than 3mg/dose) and sodium (less than 1mmol of per dose).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ondansetron

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known.
List of Excipients

Citric acid anhydrous
Sodium citrate dihydrate
Sodium benzoate (E211)
Xylitol (E967)
Strawberry flavour (contains propylene glycol and ethanol)
Purified water

Pack sizes and marketing

A type III amber glass bottle with a tamper evident aluminium cap with an EPE liner, or a child resistant polypropylene cap with an EPE liner, containing 50ml.

Marketing authorization holder

Focus Pharmaceuticals Ltd, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20046/0036

13/09/2011

 
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