ROBITUSSIN COUGH AND CHEST CONGESTION Oral solution Ref.[50683] Active ingredients: Demorphan Guaifenesin

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2023  Publisher: Pfizer New Zealand Limited, P O Box 3998, AUCKLAND 1140, New Zealand, Toll Free: 0800 447 400, Web: www.robitussin.co.nz

Product name and form

Robitussin Cough & Chest Congestion.

Pharmaceutical Form

Oral solution.

Qualitative and quantitative composition

Each 1 mL of oral solution contains: Guaifenesin 20 mg, Dextromethorphan hydrobromide monohydrate 3 mg.

Excipient(s) with known effect:

  • Sodium benzoate
  • Sorbitol

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.

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, Sodium benzoate, Saccharin sodium, Citric acid, Propylene glycol, Sorbitol solution (70%) (crystallizing), Allura red AC, Ethanol, Menthol, Cherry flavour (vanilla) 21146, Vanilla bean flavour 52.089A, Lemon flavour No 462924, Cherry flavour 119062, Sweet artificial flavour 13540488, Purified water.

Pack sizes and marketing

Robitussin Chesty Cough Forte is a clear, red syrup with mentholated cherry flavour, packed in bottles.

Pack sizes: 25 mL (professional sample) and 45 mL (professional sample), 100 mL, 200 mL & 250 mL.

Marketing authorization holder

Pfizer New Zealand Limited, P O Box 3998, AUCKLAND 1140, New Zealand, Toll Free: 0800 447 400, Web: www.robitussin.co.nz

Marketing authorization dates and numbers

9 April 1998

Drugs

Drug Countries
ROBITUSSIN DM Hong Kong, New Zealand, Singapore

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