FENPAED Oral suspension Ref.[50138] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Product name and form

Fenpaed Ibuprofen 100 mg/5 ml Oral Suspension.

Numark Ibuprofen 100mg/5ml Oral Suspension.

Ibuprofen 100mg/5ml Oral Suspension.

Healthpoint Ibuprofen 100mg/5ml Oral Suspension.

Pharmaceutical Form

Oral Suspension.

Sugar Free, Colour Free and Strawberry Flavour.

Qualitative and quantitative composition

Each 5 ml contains 100 mg of ibuprofen.

Excipients with known effect

Maltitol liquid 1447.5 mg/5 ml
Sodium methylhydroxybenzoate 9 mg/5 ml
Sodium propylhydroxybenzoate 1 mg /5 ml
Propylene glycol 5.2 mg/5 ml (see section 4.4)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Glycerol (E422)
Xanthan gum
Maltitol liquid (E965)
Polysorbate 80
Saccharin sodium (E954)
Citric acid monohydrate
Sodium methylhydroxybenzoate
Sodium propylhydroxybenzoate
Purified water
Strawberry flavour (propylene glycol)

Pack sizes and marketing

An amber glass bottle sealed with child resistant, tamper evident cap.

Pack sizes available: 100 ml. A double ended spoon with measures of 2.5ml and 5ml is provided.

Marketing authorization holder

Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Marketing authorization dates and numbers

PL 04917/0082

12th November 2007

Drugs

Drug Countries
FENPAED New Zealand, United Kingdom

© 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.