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

4.1. Therapeutic indications

Robitussin Cough & Chest Congestion is an expectorant cough suppressant. For the temporary relief of cough and chest congestion due to cold and flu.

4.2. Posology and method of administration

Every 6 to 8 hours orally when necessary:

Adults and Children 12 years and over: 10 mL

Children 6 years – under 12 years: 5 mL

Do not exceed 4 doses in 24 hours. Do not use in children under 6 years of age. Use in children aged 6 to 11 years only on the advice of a doctor, pharmacist or nurse practitioner.

4.9. Overdose

The following signs or symptoms may be associated with an overdose of Robitussin Cough and Chest Congestion:

Gastrointestinal disorders

Nausea or severe nausea, vomiting diarrhoea and stomach pain

Nervous system disorders

Depressed level of consciousness, dizziness, dysarthria, myoclonus, nystagmus, somnolence, tremor, nervousness, irritability, restlessness, headache, drowsiness

Psychiatric disorders

Excitability, confusional state, psychotic disorder

Respiratory, thoracic and mediastinal disorders

Respiratory depression

Skin disorders

Rash

Other side effects that may occur with high doses (overdosage)

"Serotonin syndrome"

Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In the event of massive overdose the following symptoms may be observed: coma, respiratory depression, convulsions.

Management

Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of dextromethorphan within the preceding hour. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses for treatment of opioid overdose, can be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome can be used.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

Not available.

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