BENYLIN DRY COUGHS Syrup Ref.[7731] Active ingredients: Demorphan Diphenhydramine Menthol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

Product name and form

BENYLIN DRY COUGHS 7.5mg/5ml Syrup.

Pharmaceutical Form

Pale brown coloured, peach flavoured syrup.

Qualitative and quantitative composition

Each 5 ml contains: Dextromethorphan hydrobromide 7.5 mg.

Each 5ml also contains:

Sucrose 1.6g
Liquid glucose 2.38g
Sorbitol 325mg
Ethanol 240mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Demorphan

Dextromethorphan is a non-opioid antitussive drug. The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and δ-receptors. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA) receptors.

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.

Menthol
List of Excipients

Liquid glucose
Sucrose
Sorbitol solution 70% non crystallising
Ethanol 96%
Glycerol
Saccharin sodium
Citric acid monohydrate
Sodium benzoate
Caramel T12
Imitation peach flavour
Levomenthol
Carbomer
Purified Water

Pack sizes and marketing

125 or 150 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad.

Marketing authorization holder

McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

Marketing authorization dates and numbers

15513/0051

Date Granted: 16 June 1997

Drugs

Drug Countries
BENYLIN Cyprus, Ireland, Malta, United Kingdom

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