ROBITUSSIN CHESTY COUGH MEDICINE Oral solution Ref.[50001] Active ingredients: Guaifenesin

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 Chesty Cough Medicine.

Pharmaceutical Form

A deep wine-russet coloured oral solution with a raspberry odour and taste.

Qualitative and quantitative composition

Active Ingredient:

Guaifenesin Ph Eur 100mg per 5ml.

Excipients with known effect:

Ethanol: 242 mg of alcohol (ethanol) per 10 ml dose.

Maltitol (E965): 484 mg of maltitol per 10 ml dose.

Propylene glycol (E1520): 15.2 mg propylene glycol per 10 ml dose.

Sodium benzoate (E211): 12.0 mg of sodium benzoate per 10 ml dose.

Sodium: 23.9 mg of sodium per 10 ml dose.

Sorbitol (E420): 2675 mg sorbitol per 10 ml dose.

For full list of excipients see section 6.1.

Active Ingredient Description
Guaifenesin

Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions. Guaifenesin is over-the-counter drug for the treatment of cough and common cold.

List of Excipients

Glycerol
Carmellose sodium
Sodium benzoate (E211)
Sodium cyclamate
Ethanol (96%)
Levomenthol
Maltitol (E965)
Sorbitol solution 70%
Natural cherry flavouring
Citric acid anhydrous
Caramel (E150)
Acesulfame potassium
Purified water

Pack sizes and marketing

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

A clear polypropylene measuring cap is also included.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 44673/0206

1 September 1993

Drugs

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

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