OTRIVINE ADULT Nasal spray, solution Ref.[49999] Active ingredients: Xylometazoline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Otrivine Adult Nasal Spray.

Pharmaceutical Form

Nasal spray, solution.

The spray is a clear, colourless solution.

Qualitative and quantitative composition

Xylometazoline Hydrochloride 0.1% w/v.

For excipients, see section 6.1.

Active Ingredient Description
Xylometazoline

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
Disodium phosphate dodecahydrate (Sodium phosphate)
Disodium edetate
Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)
Sodium chloride
Purified water

Pack sizes and marketing

Bottle: Low density polyethylene

Cap: High density polyethylene

Spray valve and capillary: Low density polyethylene

Carton: Cardboard

Pack size: 10 ml.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

PL 44673/0149

1st October 1997/19th August 2010

Drugs

Drug Countries
OTRIVINE Ireland, Turkey, United Kingdom

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