1. Name of the medicinal product
Benylin Mucus Cough & Cold All in One Relief Tablets

Sudafed Mucus Relief Triple Action Cold & Flu Tablets

Benylin Chesty Cough & Cold Tablets

2. Qualitative and quantitative composition

Active Ingredient

Paracetamol

Guaifenesin

Phenylephrine Hydrochloride
 mg/Tablet

250

100

5
 

For full list of excipients, see section 6.1.

3. Pharmaceutical form
Film-coated tablet

White capsule shaped tablet, embossed with “PGP”, free from specks and blemishes.

4. Clinical particulars
4.1 Therapeutic indications
For the relief of symptoms associated with colds and flu, including aches and pains, headache, blocked nose and sore throat, chills and chesty cough.

4.2 Posology and method of administration
For oral use. Take tablets with water. Swallow whole, do not chew.

Adults, the Elderly and children aged 12 years and over:

Two tablets. Repeat every four hours as required. Do not take more than 8 tablets (4 doses) in any 24 hour period.

Do not give to children under 12 years, except on medical advice.

Do not take more medicine than the label tells you to.

4.3 Contraindications
Hypersensitivity to paracetamol or any of the other ingredients.

Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors (see section 4.5).

Use in patients with glaucoma or urinary retention.

Use in patients who are currently receiving other sympathomimetic drugs.

Phaeochromocytoma.

Closed angle glaucoma.
4.4 Special warnings and precautions for use
The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations).

Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Patients suffering from chronic cough or asthma should consult a physician before taking this product.

Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.

Do not take with a cough suppressant.

Medical advice should be sought before taking this product in patients with these conditions:

An enlargement of the prostate gland

Occlusive vascular disease (e.g. Raynaud's Phenomenon)

Cardiovascular disease

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Concomitant use of other paracetamol-containing products should be avoided. If symptoms persist consult your doctor.

Use with caution in patients with circulatory disorders such as Raynaud's Phenomenon.

Patients with prostatic hypertrophy may have increased difficulty with micturition.

Sympathomimetic-containing products may act as cerebral stimulants giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform con