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SUDAFED NOSE SPRAY Aqueous solution (2019)

Active ingredients: Pseudoephedrine

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.

Chemical substance
Description
Pseudoephedrine

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.

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
Authorization dates

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

21/April/1999

Marketing authorization number:

PL 15513/0074