PARACETAMOL 120mg/ 5ml Sugar-Free Infant Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

McNeil Healthcare (Ireland) Ltd

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:

Not marketed

Authorization date:

2010-11-05

Patient Information leaflet

PARACETAMOL
_120 mg/5 ml Sugar Free _X
_INFANT ORAL SUSPENSION _
_Contains Paracetamol_
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 Paracetamol Sugar Free Infant Oral Suspension
is and what it is used for
2.
What you need to know before you use Paracetamol
Sugar Free Infant Oral Suspension
3.
How to use Paracetamol Sugar Free Infant Oral
Suspension
4.
Possible side-effects
5.
How to store Paracetamol Sugar Free Infant Oral
Suspension
6.
Contents of the pack and other information
1 WHAT PARACETAMOL SUGAR FREE INFANT
ORAL SUSPENSION IS AND WHAT IT IS USED FOR
The paracetamol in Paracetamol Sugar Free 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
PARACETAMOL SUGAR FREE INFANT ORAL
SUSPENSION
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 PARACETAMOL SUGAR FREE
INFANT ORAL SUSPENSION.
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

Summary of Product characteristics

Health Products Regulatory Authority
07 April 2022
CRN00CSYN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PARACETAMOL 120mg/ 5ml Sugar-Free Infant Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PARACETAMOL Sugar Free Infant Suspension contains 120 mg Paracetamol
in each 5 ml.
Excipients with known effect (per 5ml):
Maltitol Liquid Ph. Eur (E965)
2.0 ml
Sorbitol Liquid (E420)
0.75 ml
Methyl parahydroxybenzoate (E218)
5.0 mg
Propyl parahydroxybenzoate (E216)
1.0 mg
Ethyl parahydroxybenzoate (E214)
2.0 mg
Carmoisine (E122)
0.075 mg
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension.
A pink suspension with a strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PARACETAMOL Sugar Free Infant Suspension is indicated for the
treatment of pain (including teething pain), and as an
antipyretic.
PARACETAMOL 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
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 babyweighs 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.
CHILDREN AGED 3 MONTHS – 6 YEARS:
CHILD'S AGE
HOW MUCH
HOW OFTEN (IN 24 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
10ml (5 ml + 5 ml)
4 times
Health Products Regulatory Authority
07 April 2022
CRN00CSYN
Page 2 of 8

Do not give more than 4 doses in any 2