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

Product name and form

Non-Drowsy Sudafed Decongestant Nasal Spray.
Sudafed Blocked Nose Spray.
Sudafed Mucus Relief 0.1% Nasal Spray.
Sudafed Sinus-Ease 0.1% Nasal Spray.

Pharmaceutical Form

Aqueous solution.

Qualitative and quantitative composition

This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation.

For the full list of excipients, see section 6.1.

Active Ingredient Description

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.


Xylometazoline acts directly on α-adrenoreceptors but does not act on β-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.

List of Excipients

Benzalkonium chloride solution
Disodium edetate
Sodium dihydrogen phosphate dihydrate
Sodium monohydrogen phosphate dihydrate
Sodium chloride
Sorbitol solution, 70% (Non crystalline)
Purified water

Pack sizes and marketing

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.

Marketing authorization holder

McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Marketing authorization dates and numbers

PL 15513/0074



Drug Countries
SUDAFED Canada, Cyprus, Estonia, Lithuania, Malta, Poland, Turkey, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.