CALPROFEN Oral suspension Ref.[6922] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Product name and form

Calprofen 100mg/5ml Oral Suspension Ibuprofen.

Pharmaceutical Form

Oral Suspension.

Sugar Free, Colour Free and Strawberry Flavour.

Qualitative and quantitative composition

Ibuprofen 100 mg/5 ml.

Also contains maltitol syrup (E965), sodium methylhydroxybenzoate (E219), sodium propylhydroxybenzoate (E217), propylene glycol (E1520) and ethanol.

For 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 syrup (Lycasin 80/55 (E965))
Polysorbate 80
Saccharin sodium (E954)
Citric acid monohydrate
Sodium methylhydroxybenzoate (E219)
Sodium propylhydroxybenzoate (E217)
Purified water
Strawberry flavour (containing propylene glycol (E1520) and ethanol)

Pack sizes and marketing

Amber glass bottle sealed with a child resistant, tamper evident cap. A syringe with a 2.5 ml and 5 ml measure is supplied with this pack.

Pack sizes: 100ml.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 15513/0147

21st July 2006

Drugs

Drug Countries
CALPROFEN United Kingdom

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