BELARMIN Syrup Ref.[107306] Active ingredients: Diphenhydramine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Belarmin 14 mg/5 ml syrup.

Pharmaceutical Form

Syrup.

Red, clear, flavoured liquid.

Qualitative and quantitative composition

Each 5 ml of syrup contains 14 mg diphenhydramine hydrochloride.

Excipients with known effect: Each 5 ml of syrup contains 2.39 g sucrose, 0.45 g sorbitol E420, 162 mg ethanol, 5 mg sodium benzoate E211 and 0.5 mg Ponceau 4R E124.

For the 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

Ammonium chloride
Citric acid
Sodium benzoate E211
Menthol
Raspberry flavour
Ponceau 4R E124
Sucrose
Sorbitol E420
Ethanol 96%
Purified water

Pack sizes and marketing

Cardboard box containing one amber glass bottle (type III) closed with a plastic child resistant closure. One measuring spoon of 5 ml (graduated every 2.5 ml) is also supplied with the pack.

Pack size of 100 ml syrup.

Marketing authorization holder

Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

7739

Date of first authorization: 02 February 1981
Date of latest renewal: 20 May 2013

Drugs

Drug Countries
BELARMIN Cyprus

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