Skip to Content

UK Edition. Click here for US version.

CARE INFANT PARACETAMOL 120MG/5ML SUSPENSION

Active substance(s): PARACETAMOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Turn over

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 520335
Suf fix

CRN

11163

Reason for
Change

Update in line with PRAC
recommendations.

A

Issued by
Date

MHRA/IMB
submission Yes
required

Helvetica Neue LT

Helvetica LT

28.05.2014
Date

Helvetica
Process Black + 20%

Keyline (Does not print)

1

• Changes in the blood may occur which may
cause unusual bruising or an increase in the
number of infections (e.g. sore throats) which
your child gets.
• Very rare cases of serious skin reactions have
been reported.
23093407

Data Matrix: 23093407 VERIFIED

Fonts Used

Very rare side effects:

Proof No.

Age
Dose- up to 4 times in 24hrs
3–6 mths
2.5ml
6–24 mths 5ml
2–4 years
7.5ml (5ml + 2.5ml)
4–6 years
10ml (5ml + 5ml)
• 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

338mm x 148mm flat (29mm x 148mm folded)

Check the tables below to see how much of the
medicine to use
• For oral use only.
• It is important to shake the bottle for at least
10 seconds before each use.
• Never give more medicine than shown in the table.
• Always use the syringe supplied with the pack.
• Do not give with any other paracetamolcontaining product.

• If you think your child has any of the following
serious side effects or symptoms, stop using
this medicine and see a doctor as soon as
possible.
• Allergic reactions (swelling of the face, lips,
tongue or throat, difficulty in swallowing or
breathing, skin rash).

Dimensions

• Domperidone or metoclopramide for nausea and
sickness.
• Colestyramine mainly used for high cholesterol.
• Medicines used to prevent blood clotting such as
warfarin.

3.How to use this medicine

Important side effects:

23093407

Talk to your doctor or pharmacist if
your child is taking....

Like all medicines, Care Infant Paracetamol
Suspension can have side effects, although these
don’t affect everyone.

100ml

• Severe kidney or severe liver problems.

NEW DOSAGE INSTRUCTIONS
Dose
Age
For post-vaccination One x 2.5ml dose.
fever for babies
If necessary, after 4-6 hours, give
between 2-3 months a second 2.5ml dose
• Do not give to babies less than 2 months of age • Do not
give more than 2 doses • Leave at least 4 hours between
doses • If further doses are needed, talk to your doctor or
pharmacist

4. Possible side effects

IG Code

Now read the rest of the leaflet before you use
this medicine. It includes other information
which might be especially important for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need any more
information or advice.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Talk to your doctor or pharmacist if
your child has….

• This medicine contains maltitol and sorbitol. If
you have been told by your doctor that your child
has an intolerance to some sugars, contact your
doctor before giving this medicine.
• It also contains sodium parahydroxybenzoates
(E219) which may cause allergic reactions
(possibly delayed).

If you forget a dose

Give the next dose as soon as you remember.
Do not give a double dose. You can then carry on
with the normal dose at the correct time.

Pack Size

Seek immediate medical help in the event of an
overdose. See section 3.

Important information about some of
the ingredients

If you give too much

Talk to a doctor at once if your child takes too
much of this medicine even if they seem well.
This is because too much paracetamol can cause
delayed, serious liver damage.
Take the pack with you to show which medicine
your child has swallowed.

Leaflet

• Has an allergy to any of the ingredients listed in
section 6.
• Is taking any other product containing
paracetamol.

Do not give more medicine than the label tells you to.
If your child does not get better, talk to your doctor.

Component

Do not use the medicine if your
child….

Pregnant or breastfeeding….

Ask your doctor or pharmacist for advice before
taking this medicine if you are pregnant or
breastfeeding.

How to use the syringe

• Shake the bottle for at least 10 seconds.
• With the bottle in the upright position remove
the cap.
• Insert the syringe into the bottle.
• Holding the syringe in place, gently pull up the plunger
to fill the syringe then remove it from the bottle.
• Remove the surplus liquid from the outside of the
syringe using a tissue.
• Adjust the amount to the 2.5ml or 5ml mark as
appropriate (see table for correct dose).
• Place the syringe inside the child's mouth against
the cheek and press the plunger slowly to gently
release the medicine.
• After use, wipe the bottle neck clean and rinse the
cap before replacing.
• The syringe should be washed and dried after use.
It can be cleaned by hand or in a dishwasher.

Colours Used

2.Before you use this
medicine

This product is intended for use by children under
6 years old. However, the following additional
warnings are included in case an adult is taking
this medicine.
This medicine may be harmful if you have
alcoholic liver disease.

Care Infant Paracetamol 120mg/5ml
Suspension

Do not give….
• With any other products containing paracetamol.
• For longer than 3 days without seeing your
doctor.
• To infants under 3 months old except for fever
after vaccination at 2 months.

Care Infant Paracetamol Suspension relieves mild
to moderate pain including teething pains. It also
reduces fever including high temperature caused
by vaccinations.
This medicine contains paracetamol which has
pain relieving properties and also acts to bring
down high temperature.

Can adults take this medicine?

Product
Title

FRONT FACE TOP

Important information about Care Infant
Paracetamol 120mg/5ml Suspension
• This medicine reduces fever and relieves mild to
moderate pain in infants and children between 3
months and 6 years old.
• Follow the dosage instructions carefully. Children
of different ages need different amounts. See
section 3.

1.What the medicine is for

MHRA Header Box

Care Infant Paracetamol
120mg/5ml Suspension

Data Matrix: 23093407 VERIFIED

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 520335
Suf fix

CRN

11163

Reason for
Change

Update in line with PRAC
recommendations.

A

Issued by
Date

MHRA/IMB
submission Yes
required

28.05.2014

338mm x 148mm flat (29mm x 148mm folded)
Dimensions

Date

23093407
IG Code

1

100ml
Pack Size

23093407

Leaflet

The active ingredient per 5ml is:
paracetamol 120mg.
The other ingredients are:
sodium methyl parahydroxybenzoate (E219),
sodium propyl parahydroxybenzoate, citric acid
anhydrous, saccharin sodium, glycerol, dispersible
cellulose, strawberry flavour (contains propylene
glycol), acesulphame K, carmine (E120), maltitol
liquid (which contains maltitol E965 and sorbitol
E420), xanthan gum (E415), potassium hydroxide
and purified water.

Component

What the medicine contains

Care Infant Paracetamol 120mg/5ml
Suspension

6.Further information

Product
Title

Colours Used

• Keep it out of the reach and sight of children.
• Do not store above 25°C but do not refrigerate.
• Protect from light. Store in the original package.
• Do not use after the expiry date shown on the
carton. The expiry date refers to the last day of
that month.
• Medicine should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

MHRA Header Box

REVERSE FACE TOP

5.Storing this medicine

Proof No.

This leaflet was revised in May 2014

Helvetica LT

Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK.

Keyline (Does not print)

Marketing authorisation holder and
manufacturer

Process Black + 20%

Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from
10am to 2pm Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

Fonts Used

Making medicines safer:

Helvetica

Care Infant Paracetamol Suspension is a pale pink
cloudy suspension which tastes of strawberry.
It is supplied in 100ml bottles.

Helvetica Neue LT

What the medicine looks like

If you notice these or any other side effect not
included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide