1. Name of the medicinal product
Bronchial Cough Mixture
2. Qualitative and quantitative composition
Active ingredients
Guaifenesin Ph Eur
32.5mg/5ml
Ammonium chloride Ph. Eur.
150mg/5ml
Ammonium carbonate HSE
100mg/5ml
3. Pharmaceutical form
Oral liquid
4. Clinical particulars
4.1 Therapeutic indications
For the relief of chesty coughs and colds on the chest.
For oral administration.
4.2 Posology and method of administration
Adults and children over 12 years: 10ml
The dose should be taken with twice its volume of water three or four times in 24 hours.
Children under 12 years: Not recommended
Elderly: The normal adult dose is still appropriate in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions.
4.6 Pregnancy and lactation
The safety of this product during pregnancy has not been established, although there is no good evidence of an association between first trimester exposure to either ammonium chloride or guaiphenesin and foetal abnormalities. The safety of the product during lactation has not been established, although use during this period would not be considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
May occasionally produce gastrointestinal discomfort, nausea and vomiting.
4.9 Overdose
Symptoms of overdosage include nausea, vomiting, thirst, headache, hyperventilation and progressive drowsiness, leading to profound acidosis and hypokalaemia.
Treatment consists of the correction of acidosis and electrolyte loss by the intravenous administration of sodium bicarbonate or sodium lactate, together with potassium supplements by mouth. Otherwise treatment should be symptomatic and supportive.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Ammonium chloride and ammonium carbonate have an irritant effect on mucous membranes and are considered to have expectorant properties.
Guaiphenesin is thought to reduce the viscosity of tenacious sputum and has expectorant properties.
5.2 Pharmacokinetic properties
Ammonium salts are effectively absorbed from the gastrointestinal tract. The ammonium ion is converted into urea in the liver; the anion thus liberated into the bloodstream and extracellular fluid causes a metabolic acidosis and decreases the pH of the urine, this is followed by a transient diuresis.
Guaiphenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium saccharin
Liquorice flavour 15020064 IFF
Chloroform
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
None
6.5 Nature and contents of container
White flint or amber glass bot
