CALPOL INFANT Oral suspension Ref.[27716] Active ingredients: Paracetamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form

CALPOL Infant Suspension.

Pharmaceutical Form

Oral Suspension.

A pink strawberry flavoured suspension.

Qualitative and quantitative composition

CALPOL Infant Suspension contains 120mg Paracetamol in each 5ml.

Excipients: sucrose (contains 2.2 g of sucrose per 5 ml), sorbitol liquid ((E420) contains 0.45 g sorbitol liquid per 5ml), sodium (contains 0.86mg per 5ml), propylene glycol (E1520), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and carmoisine (E122). See section 4.4 for further information.

For the 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

Sucrose
Sorbitol Liquid (Non Crystallising) (E420)
Glycerol
Xanthan Gum
Microcrystalline cellulose and carmellose sodium
Polysorbate 80
Acesulfame Potassium
Propyl Parahydroxybenzoate (E216)
Ethyl Parahydroxybenzoate (E214)
Strawberry Flavour 500018E (containing propylene glycol (E1520))
Methyl parahydroxybenzoate (E218)
Carmoisine (E122)
Purified Water

Pack sizes and marketing

Amber glass bottle with a two-piece white plastic child-resistant external cap, fitted with an inner plastic cap, including a tamper evident ring fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

Or

Amber glass bottle with a two-piece white plastic child-resistant external cap, fitted with an inner plastic cap, including a tamper evident ring, in high density polyethylene. The cap contains a plug made of Low Density Polyethylene (LDPE).

Pack sizes 140 and 200 ml. A syringe with a 5 ml and 2.5 ml measure is supplied with this pack. Not all pack sizes may be marketed.

Marketing authorization holder

McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 15513/0004

28 April 1997 / 31st March 2003

Drugs

Drug Countries
CALPOL Cyprus, Ireland, Malta, Poland, Singapore, Turkey, United Kingdom, South Africa

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