SULFASALAZINE Oral suspension Ref.[7790] Active ingredients: Sulfasalazine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Product name and form

Sulfasalazine 250mg/5ml Oral Suspension

Pharmaceutical Form
Oral Suspension.

Qualitative and quantitative composition

Sulfasalazine 250mg/5ml.

Active Ingredient	Description
Sulfasalazine	Therapeutic benefit of sulfasalazine appears to be due to a local action of the sulfasalazine and its split product 5-aminosalicylic acid on the mucous membrane and deeper colonic structures.

List of Excipients
Citric acid monohydrate (E330) Sodium citrate (E331) Sodium benzoate (E211) Acesulfame K (E950) Polysorbate 80 Dispersible cellulose Xanthan gum (E415) Terpeneless lemon oil Orange/tangerine flavour (containing ethanol and butylated hydroxyanisole E320)) Purified water

Pack sizes and marketing

Bottle: Amber (Type III) glass.

Closure: HDPE, EPE wadded, tamper evident, child resistant closure.

Pack: 1 bottle containing 500ml of liquid.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Marketing authorization dates and numbers

PL 00427/0196

Change of ownership: 11/11/2008
Date of renewal: 03/08/2009

Next: Usage >

© 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.