CALPOL SUGAR FREE INFANT
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
PARACETAMOL
Available from:
G & A Licensing Limited
Dosage:
120 MG/5ml
Pharmaceutical form:
Oral Suspension
Authorization date:
2010-11-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calpol Sugar Free Infant Oral Suspension contains 120mg paracetamol in each 5ml.
Excipients: also includes the following substances in each 5ml:
Maltitol liquid
Sorbitol solution (E420)
Ethyl parahydroxybenzoate (E214)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Carmoisine (E122)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
_Product imported from _the UK:
A pink suspension with a strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CALPOL Sugar Free Infant Suspension is indicated for the treatment of pain (including teething pain), and as an
antipyretic.
Calpol Sugar Free Infant Suspension is indicated for the relief of headache, migraine, neuralgia, toothache and teething
pains, sore throat, rheumatic aches and pains, influenza, feverishness and feverish colds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
POSOLOGY
_CHILDREN AGED 6 YEARS TO 12 YEARS:_
Oral. 10 to 20 ml (240 mg to 480 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per
24 hours.
_CHILDREN AGED 1 TO UNDER 6 YEARS:_
Oral. 5 to 10ml (120 mg to 240 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per
24 hours.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/10/2011_
_CRN 2107054_
_page number: 1_
_INFANTS 3 MONTHS TO UNDER 1 YEAR:_
Oral. 2.5 to 5 ml (60 mg to 120 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per
24 hours.
_INFANTS 2-3 MONTHS (>3KG BODY WEIGHT):_
Oral 2.5ml (60mg para
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