WELLDORM ELIXIR Oral solution Ref.[9779] Active ingredients: Chloral hydrate

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire, SN8 1LW

Product name and form

Welldorm Elixir.

Chloral Hydrate 143mg per 5ml Oral Solution.

Pharmaceutical Form
Oral solution.

Qualitative and quantitative composition

Each 5ml of Chloral Hydrate Oral Solution contains 143.3mg of Chloral hydrate BP.

Active Ingredient	Description
Chloral hydrate	Chloral hydrate leads to a decrease in sleep latency and in the number of awakenings. A near natural sleep is induced and the REM/Non-REM ratio is not altered.

List of Excipients
In addition to the active ingredient, Chloral Hydrate Oral Solution contains: Glycerol Liquid glucose Sodium benzoate Saccharin sodium Permitted colours E124, E110 Essence of passion fruit Purified water

Pack sizes and marketing

Amber glass bottle with child-proof plastic screw cap, containing 150ml or 30ml of Chloral Hydrate Oral Solution, presented in a carton.

Marketing authorization holder

Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire, SN8 1LW

Marketing authorization dates and numbers

PL 23138/0016

Marketed since 1957

Date of Renewal: 13^th December, 1998

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