ROBITUSSIN DRY COUGH MEDICINE Liquid for oral administration Ref.[49979] Active ingredients: Demorphan

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

Product name and form

Robitussin Dry Cough Medicine.

Pharmaceutical Form
Bright pink clear liquid for oral administration.

Qualitative and quantitative composition

Active Ingredient: Dextromethorphan Hydrobromide Ph Eur 7.5mg per 5ml.

Excipients with known effect:

Amaranth (E123) - 0.33 mg of Amaranth in each 10 ml dose.

Ethanol: 219.3 mg of alcohol (ethanol) in each 10 ml dose.

Maltitol (E965): 484 mg of Maltitol in each 10 ml dose.

Sodium: 21.94 mg of Sodium in each 10 ml dose.

Sodium benzoate (E211): 12.0 mg of Sodium Benzoate in each 10 ml dose.

Sorbitol (E420): 2094 mg sorbitol in each 10 ml dose.

For 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.

List of Excipients
Glycerol Sodium carboxymethyl cellulose Sodium benzoate Disodium edetate Maltitol (E965) Ethanol (96%) Citric acid anhydrous Amaranth (E123) Caramel (E150) Levomenthol Cherry/Grenadine flavour Sorbitol solution 70% Sodium cyclamate Acesulfame potassium salt Purified water

Pack sizes and marketing

PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap also included.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

Marketing authorization dates and numbers

PL 44673/0207

01 September 1993

Drugs

Drug	Countries
ROBITUSSIN DRY COUGH	Ireland, New Zealand, United Kingdom

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.