PANADOL BABY Oral suspension Ref.[108763] Active ingredients: Paracetamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Haleon Ireland Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Panadol Baby 120 mg/5 ml, Oral Suspension.

Pharmaceutical Form

Oral suspension.

Opaque to translucent, white to slightly brownish suspension.

Qualitative and quantitative composition

Each 5 ml measure of suspension contains paracetamol 120mg.

Excipients:

Each 5ml contains: Sorbitol 0.75g, Maltitol 2.7g, and Parahydroxybenzoates 12.2mg (E216, E218).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Sorbitol (70%) Liquid, non-crystallising
Xanthan gum
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Citric acid anhydrous
Tri-Sodium citrate dihydrate
Glycerin
Strawberry flavour
Disodium EDTA
Sucralose
Maltitol syrup
Purified water

Pack sizes and marketing

Amber glass bottles fitted with Clic-loc closures with expanded polyethylene/polypropylene liners. Pack sizes: 60ml, 100ml, 140ml and 200ml.

10 mL plastic dosing syringe consists of a barrel (body) & plunger (slider) made from Polyethylene and Polypropylene plastic grades.

Not all pack sizes may be marketed.

Marketing authorization holder

Haleon Ireland Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0678/039/003

Date of first authorisation: 22 December 1992
Date of last renewal: 22 December 2007

Drugs

Drug Countries
PANADOL Australia, Cyprus, Estonia, Finland, Hong Kong, Croatia, Ireland, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom

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