SUDAFED NOSE SPRAY Aqueous solution Ref.[6461] Active ingredients: Pseudoephedrine Xylometazoline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Therapeutic indications

This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.

Posology and method of administration


Adults and children 12 years and over

One spray to be expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 sprays in 24 hours.

Use for more than seven consecutive days is not recommended, [See section 4.4].

Children under 12 years

Do not give to children under 12 years of age.

The Elderly

Experience has indicated that normal adult dosage is appropriate, [See section 5.2].

Hepatic/renal dysfunction

Normal adult dosage is appropriate, [See section 5.2].

Method of administration




Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an α2-adrenergic agonist could be expected to produce effects similar to those of clonidine with a short lived rise in blood pressure, followed by more prolonged hypotension and sedation.


Treatment of overdose should be supportive.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Amber glass bottle of either 10 ml or 15 ml nominal fill volume.

The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off overcap.

Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

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