SUDAFED NOSE SPRAY Aqueous solution

Active ingredients: Xylometazoline

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

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



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