CHLORDIAZEPOXIDE Capsules Ref.[7216] Active ingredients: Chlordiazepoxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Athlone laboratories Limited, Ballymurray, Co. Roscommon, Ireland

Product name and form

Chlordiazepoxide 5mg Capsules.

Pharmaceutical Form

Capsule.

Qualitative and quantitative composition

Chlordiazepoxide Hydrochloride Ph. Eur. 5 mg

Active Ingredient Description
Chlordiazepoxide

Chlordiazepoxide has anxiolytic and central muscle relaxant properties. It has little autonomic activity. Chlordiazepoxide acts as depressant of the central nervous system producing all levels of CNS depression, from mild sedation to hypnosis, to coma depending on the dose.

List of Excipients

Lactose monohydrate
Maize Starch
Magnesium Stearate

Capsule Shell Composition:

Indigo Carmine (E132)
Titanium dioxide (E171)
Erythrosine (E127)
Quinoline yellow (E104)
Gelatin

Printing Ink Composition:

Shellac
Dehydrated alcohol
Isopropyl alcohol
Butyl alcohol
Propylene glycol
Strong Ammonia Solution
Purified water
Potassium hydroxide
Titanium dioxide (E171)

Pack sizes and marketing

Polypropylene tablet containers with low density polyethylene caps.

Pack sizes: 28, 30, 56, 60, 100 and 500 capsules.

White opaque PVC/PVdC 250mm / 40 gsm film and 20mm aluminium foil.

Pack sizes: 28, 30 and 100 capsules.

Marketing authorization holder

Athlone laboratories Limited, Ballymurray, Co. Roscommon, Ireland

Marketing authorization dates and numbers

PL 06453/0002

19th March 2003

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