UNISOM SLEEPGELS Capsule Ref.[50437] Active ingredients: Diphenhydramine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Telephone: 09 377 3336

Product name and form

Unisom SleepGels 50mg capsules.

Pharmaceutical Form

Liquid filled, blue soft gelatine capsules imprinted with the word UNISOM.

Qualitative and quantitative composition

Each liquid-filled blue, soft gelatine capsule is imprinted UNISOM and contains 50 mg of mdiphenhydramine hydrochloride.

For full list of excipients, see section 6.1.

Active Ingredient Description
Diphenhydramine

Diphenhydramine is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on H1-receptors. Diphenhydramine is effective in reducing sleep onset (i.e., time to fall asleep) and increasing the depth and quality of sleep.

List of Excipients

Each capsule contains diphenhydramine hydrochloride USP 50 mg with Macrogol 400, glycerol, gelatin, sorbitol, brilliant blue FCF, polyvinyl acetate phthalate, shellac, titanium dioxide, propylene glycol and purified water.

Pack sizes and marketing

Blister pack of 10 capsules.

Marketing authorization holder

Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Telephone: 09 377 3336

Marketing authorization dates and numbers

12/2/1996

Drugs

Drug Countries
UNISOM Canada, New Zealand

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