Calpol 120 mg/5 ml Infant Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

120 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

1993-04-01

Patient Information leaflet

Package leaflet: Information for the user
Read all of this leaflet carefully before you start using this
medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
■
Keep this leaflet. You may need to read it again.
■
Ask your pharmacist if you need more information or advice.
■
If your child gets any side-effects, talk to your doctor or
pharmacist.
This includes any possible side-effects not listed in this leaflet.
See
section 4.
■
You must talk to a doctor if your child does not feel better or feels
worse after 3 days.
What is in this leaflet
1. What CALPOL
®
is and what it is used for
2. What you need to know before you use CALPOL
®
3. How to use CALPOL
®
4. Possible side-effects
5. How to store CALPOL
®
6. Contents of the pack and other information
1
What Calpol
®
is and what it is
used for
The paracetamol in
CALPOL
®
120 mg/5 ml Infant Oral Suspension
is used to relieve pain such as tooth pain, headache, sore throat and
aches and pains that come with colds and flu. It also brings down
fever
(high temperature).
2
What you need to know before
you use Calpol
®
Do not give your child this medicine…
■
If s/he has ever had a bad reaction to paracetamol or any of
the other ingredients in this medicine (see section 6).
■
If s/he is taking anything else with paracetamol in it.
■
If s/he weighs less than 4 kg.
If any of these applies, get advice from a doctor or pharmacist
without using CALPOL
®
.
Warnings and precautions
Talk to your doctor or pharmacist…
■
If your child has serious kidney or liver problems.
■
If your child has an inherited intolerance to fructose or been
diagnosed with an intolerance to some other sugars.
■
If your child has Gilbert’s syndrome (familial non-haemolytic
jaundice).
■
If your child has a condition called Glucose-6-phosphate
dehydrogenase deficiency.
■
If your child has haemolytic anaemia.
■
If your child has glutathione deficiency.
■
If

Summary of Product characteristics

Health Products Regulatory Authority
11 April 2022
CRN00CSYF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol 120 mg/5 ml Infant Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calpol Infant Oral Suspension contains -
Paracetamol 120 mg per 5 ml.
Excipients with known effect (per 5ml):
Sucrose 2202.48mg
Sorbitol Liquid (E420) 451.5mg
Propylene glycol (E1520) 13.63mg
Methyl parahydroxybenzoate (E218) 5.0mg
Propyl parahydroxybenzoate (E216) 1.0mg
Ethyl parahydroxybenzoate (E214) 2.0mg
Sodium 0.86mg
Carmoisine (E122) 0.075mg
Ethanol 0.008mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A viscous pink coloured suspension with a strawberry odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calpol Infant Suspension is indicated for the treatment of pain
(including teething pain), and as an antipyretic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
INFANTS AGED 2-3 MONTHS:
AGE : 2 – 3 MONTHS
DOSE
1 . POST-VACCINATION FEVER
2.5 ml
If necessary, after 4 - 6 hours, give a second
2.5 ml dose
2 . OTHER CAUSES OF PAIN AND FEVER - if your baby weighs over 4 kg and
was born
after 37 weeks

Do not give to babies less than 2 months of age.

Do not give more than 2 doses unless your doctor or nurse has advised
otherwise.

Leave at least 4 hours between doses.

If further doses are needed, talk to your doctor or pharmacist.

It is important to SHAKE THE BOTTLE for at least 10 seconds before
use.
Health Products Regulatory Authority
11 April 2022
CRN00CSYF
Page 2 of 8
CHILDREN AGED 3 MONTHS – 6 YEARS:
CHILD’S AGE
HOW MUCH
HOW OFTEN (IN 2 4 HOURS)
3 – 6 months
2.5 ml
4 times
6 – 24 months
5 ml
4 times
2 – 4 years
7.5ml (5 ml + 2.5 ml)
4 times
4 – 6 years
10 m l (5 ml + 5 ml)
4 times

Do not give more than 4 doses in any 24 hour
period

Leave at least 4 hours between doses

Do not give this medicine to your child for more
than 3 days without speaking to your doctor or
pharmacist
THE ELDERLY:
In t