1. Name of the medicinal product
Sudafed Chesty Coughs with Decongestant Liquid

Benylin MUCUS Cough plus Decongestant Syrup
2. Qualitative and quantitative composition
This product contains 30 mg pseudoephedrine hydrochloride and 100 mg guaifenesin in each 5 ml.

For excipients see 6.1.
3. Pharmaceutical form
A clear orange-red syrup.

4. Clinical particulars
4.1 Therapeutic indications
This product is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough, which are benefited by the combination of a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses, and an expectorant.

4.2 Posology and method of administration
Adults and children aged 12 years and over:

Oral. 10 ml syrup every 4 - 6 hours up to 4 times a day.

Maximum daily dose: 40 ml

Children under 12 years:

This product is contraindicated in children under the age of 12 years (see section 4.3).

The elderly:

Normal adult dosage is appropriate, [See Pharmacokinetics in the elderly].

Hepatic dysfunction:

Experience with the use of the product suggests normal adult dosage is appropriate, although it may be prudent to exercise caution in the presence of severe hepatic impairment, [See Pharmacokinetics in the elderly].

Renal dysfunction:

Caution should be exercised when administering this product to patients with moderate to severe renal impairment, particularly if accompanied by cardiovascular disease, [See Pharmacokinetics in Renal Impairment].

Do not exceed the stated dose.

Keep out of the reach and sight of children.

4.3 Contraindications
This product is contraindicated in individuals with known hypersensitivity to the product, or any of its components.

This product is contraindicated in individuals with severe hypertension or severe coronary artery disease.

This product is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure.

Not to be used in children under the age of 12 years.

4.4 Special warnings and precautions for use
Although pseudoephedrine has virtually no pressor effects in normotensive patients, this product should be used with caution in individuals suffering from mild to moderate hypertension, [See Contraindications and interactions with other medicinal products].

As with other sympathomimetic agents, this product should be used with caution in individuals with heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure or prostatic enlargement.

This product should be not used for persistent or chronic cough, such as occurs with asthma, or emphysema where cough is accompanied by excessive secretions, unless directed by a physician.

Caution should be exercised when using the product in the presence of severe hepatic impairment or renal impairment (particularly if accompanied by cardiovascular disease), [See Pharmacokinetics].

Not more than 4 doses should be given in any 24 hours.

Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

4.5 Interaction with other medicinal products and other forms of interaction
Concomitant use of this product with anti-hypertens