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PARACETAMOL ELIXIR PAEDIATRIC BP 120MG/5ML

Active substance(s): PARACETAMOL

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Artwork Panel
Product: Paracetamol Elixir Paediatric 120mg/5ml
Client: Cox Pharmaceuticals Ltd
Date: 16/10/14
Artwork Code: N/A
Version No: A
Feverishness

Paracetamol
Elixir
Paediatric
BP 120mg/5ml

For the relief of pain and
feverish conditions in children

AGE
DOSAGE
CHILDREN 1 TO 6 YEARS One to two 5ml teaspoons every 4-6 hours.
CHILDREN 3 MONTHS Half to one 5ml teaspoon every 4-6 hours.
TO 1 YEAR
CHILDREN UNDER 3 MONTHS On doctor’s advice only.
NOT MORE THAN 4 DOSES IN ANY 24-HOUR PERIOD.
DO NOT EXCEED THE STATED DOSE.
IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR.

CONTAINS PARACETAMOL Do not give with any other Paracetamol-containing products.

IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHT IN THE
EVENT OF AN OVERDOSE, EVEN IF THE CHILD SEEMS WELL,
BECAUSE OF THE RISK OF DELAYED, SERIOUS LIVER DAMAGE.

PLEASE READ THE REVERSE OF THIS LABEL WHICH PROVIDES
IMPORTANT INFORMATION ABOUT THIS PRODUCT

Each 5ml of the
elixir contains:
Paracetamol BP 120mg.
Paracetamol is an
analgesic (reduces pain)
and an anti-pyretic
(reduces temperature).
Also contains:
Ethanol (10% v/v),
Propylene Glycol,
Invert Syrup,
Amaranth (E123),
Glycerol (E422).

BN:
EXP:

100 ml

KEEP THE CONTAINER TIGHTLY CLOSED

Artwork Ref: N/A
Pack Type: Label

Do not use this product
after its ‘EXP’ date.

Dimensions: Label Size: 47 x 140 mm
Barcode

Pain

HOW TO TAKE IT

RE T
HE NO E
EL O V
PE T D MO
BU RE

RECOMMENDED FOR

MA Holder: Cox Pharmaceutical Ltd
788-790 Finchley Road, London
NW11 7TJ, United Kingdom
PL 42671/0002
Date of last revision: Oct 2014

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

PL No: 42671/0002
Barcode:
Fonts: Helvetica Neue LT Pro Light Condensed
/medium condensed/thick

Technical NON-Printed items:
YOUR MEDICINE: Each 5ml of the elixir contains: Active Ingredient: 120mg Paracetamol. Inactive Ingredients: Ethanol (10% v/v), Propylene Glycol,
Chloroform Spirit, Concentrated Raspberry Juice, Invert Syrup, Amaranth Solution (E123) and Glycerol (E422).
WARNINGS: Do not give this medicine if the child is hypersensitive to Paracetamol or any other ingredients. Do not give with any other Paracetamol-containing products.
Please tell your doctor or pharmacist before taking this medicine; if you suffer from severe liver or kidney problems or if you are pregnant or breast-feeding.
This medicinal product contains a small amount of Ethanol (Alcohol), less than 100mg per 5ml spoonful which may cause drowsiness.
This product contains Invert Syrup (glucose & fructose). It may be harmful to the teeth. If you have been told by a doctor, that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
Caution! This medicine must not be taken by people suffering from liver disease, epilepsy, brain injury or brain disease. Reactions may be slow.
It may modify or increase the effect of other medicines.
This product contains Glycerol, which is harmful in high doses and may cause headaches, stomach upset and diarrhoea.
This product contains Amaranth and Propylene Glycol, which may cause allergic-type reactions. These reactions are more common in people who are allergic to Aspirin.
The product should not be diluted.
INTERACTIONS: Advise your doctor or pharmacist of any other medicines you are taking, as there could be an interaction between them and this product.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone (a gastric sedative) and reduced by colestyramine
(lowers cholesterol levels). The anticoagulant effect of warfarin and other coumarins (anti-coagulants) may be enhanced by prolonged regular use of paracetamol
with increased risk of bleeding, however, occasional doses have no significant effect.
IN CASE OF AN OVERDOSE: Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of serious
liver damage. There may be no symptoms during the first 24 hours though pallor, nausea, vomiting and abdominal pain may occur.
WHAT SIDE EFFECTS MAY OCCUR? Side effects are rare. Reactions such as blood disorders and skin rashes may
occasionally occur. If your child experiences these or any other side effects, consult your doctor or pharmacist.

Date of last revision: Oct 2014

Braille:
Cutter:

CUTTER

Colour References:

Pantone
Blue
2728 C

Pantone
Red
186 C

Pantone
Process
Black C

bilton by design

Paediatric
For oral administration.

For the relief of pain and
feverish conditions in children.

Barcode

PL 42671/0002
Date of last revision: Oct 2014

The Elixir contains:
Paracetamol 120mg per
5ml of Elixir.
Also contains: ethanol
(96%, 10%v/v),
Propylene Glycol,
Chloroform, Concentrated
Raspberry Juice,
Invert Syrup,
Amaranth Solution (E123),
Glycerol/Glycerine(E422).

200 ml

MA Holder:
Cox Pharmaceutical Ltd
788-790 Finchley Road,
London NW11 7TJ
United Kingdom

Artwork Panel
Product: Paracetamol Elixir Paediatric 120mg/5ml
Client: Cox Pharmaceutical Ltd
Date: 16/10/14
Artwork Code: N/A
Version No: A
Artwork Ref: N/A

Dimensions: Label Size: 60 x 165mm with 12 panel Fix-a-Form
PL No: 42671/0002
Barcode:
Braille:
Paracetamol 120mg/5ml Elixir Paediatric
Type: Marburg Medium
Dot diameter: 1.6mm
Character spacing: 6mm
Line spacing: 10mm

This medicine is available without prescription.
However, you still need to take Paracetamol Elixir
Paediatric carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do
not improve.
• If any of the side effects gets serious, or if you notice any
side effect not listed in this leaflet, please tell your doctor or
pharmacist.
Read all of this leaflet carefully because it contains
important information for you.

Paracetamol Elixir Paediatric
120mg/5ml
PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Elixir Paediatric contains the active
ingredient paracetamol and is used for the relief of
pain and feverish conditions in children.

1. WHAT PARACETAMOL ELIXIR PAEDIATRIC
IS AND WHAT IT IS USED FOR

In this leaflet:
1. What Paracetamol Elixir Paediatric is and
what it is used for
2. Before you give Paracetamol Elixir Paediatric
3. How to give Paracetamol Elixir Paediatric
4. Possible side effects
5. How to store Paracetamol Elixir Paediatric
6. Further information

Take special care with Paracetamol Elixir
Paediatric
2. BEFORE YOU GIVE PARACETAMOL ELIXIR
Consult the doctor before giving this medicine to
your child if he/she has impaired kidney or liver
function.
DO NOT give your child Paracetamol Elixir
Paediatric if he/she is:
• allergic (hypersensitive) to paracetamol, other pain
relievers or any of the other ingredients in the
product (see Section 6 and end of Section 2)
• taking any other paracetamol-containing
medicines, i.e. over-the-counter cold remedies.

2. BEFORE YOU GIVE PARACETAMOL ELIXIR

Important information about some of the
ingredients of Paracetamol Elixir Paediatric
• Ethanol (alcohol) - may cause drowsiness; this
Taking other medicines
Please tell the doctor if your child is taking, or has
recently taken, any other medicines, including
those obtained without a prescription, particularly:
• other products containing paracetamol (see ‘DO
NOT give your child Paracetamol Elixir Paediatric’
above)
• metoclopramide and domperidone (used to treat
nausea, vomiting or other stomach problems)
• cholestyramine (reduces blood cholesterol levels)
• warfarin and other drugs which thin the blood
• alcohol-containing products.

Always give Paracetamol Elixir Paediatric exactly
as the doctor has told you. For oral use only. Do
not dilute this product.

3. HOW TO GIVE PARACETAMOL ELIXIR

medicine contains less than 100mg per 5ml
spoonful.
• Invert syrup (glucose & fructose) – may be
harmful to teeth. If your child has an intolerance
to some sugars, ask the doctor before giving this
medicine.
• Amaranth - may cause allergic reactions.
• Propylene glycol - may cause alcohol-like
symptoms.
• Glycerol - may cause headache, stomach upset
and diarrhoea.

If you give more Paracetamol Elixir Paediatric than
you should
It is extremely important to follow the dosage
WARNING: DO NOT EXCEED THE STATED DOSE
Contains paracetamol. Do not give with other
paracetamol containing products.
Children:
1 - 6 years: one to two 5ml spoonfuls every 4 hours
3 - 12 months: half to one 5ml spoonful every 4
hours
Under 3 months: on doctor’s advice only.
The dose should not be repeated more frequently
than 4 hour intervals.
If symptoms persist, speak to the doctor.

Fonts:
PIL - Main Heading type style: 13pt Helvetica Bold
PIL - Sub Heading type style: 10pt Helvetica Bold
PIL - Text type style: 9pt Helvetica Light & Bold u&lc

instructions that have been given. Do not change the
dose without discussing it with the doctor first.
Symptoms of overdose include pallor (paleness of
skin), nausea, vomiting, anorexia and stomach pain.
If your child accidentally takes more than the
recommended dose, their doctor or nearest hospital
casualty immediately. Take any remaining medicine
and this leaflet with you if possible.
IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHT IN
THE EVENT OF AN OVERDOSE, EVEN IF YOUR CHILD
FEELS WELL, BECAUSE OF THE RISK OF DELAYED,
SERIOUS LIVER DAMAGE.

If you forget to give Paracetamol Elixir Paediatric
If your child misses a dose, give it as soon as you remember.
NEVER give a double dose to make up for the dose that has
been forgotten.

If you have any further questions on the use of this product,
ask the doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Elixir Paediatric
can cause side effects, although not everybody
gets them.
Your child may suffer an allergic reaction,
symptoms of which include skin rash. If this
happens, stop giving the medicine immediately and seek urgent medical help.
Blood abnormalities have also been reported but
these were not necessarily due to the paracetamol
treatment.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell the doctor.

5. HOW TO STORE PARACETAMOL ELIXIR
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original
container and keep the bottle tightly closed.
Do not use Paracetamol Elixir after the expiry date
shown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION

What Paracetamol Elixir Paediatric contains
The active substance is paracetamol, 120mg per
5ml. The other ingredients are ethanol (96%,
10%v/v), propylene glycol, chloroform,
concentrated raspberry juice, invert syrup,
amaranth solution (E123), glycerol/glycerine (E422).
See also end of Section 2 on ‘Important information
about some of the ingredients of Paracetamol Elixir
Paediatric’.
What Paracetamol Elixir Paediatric looks like
and contents of the pack
This medicine is a clear bright syrupy liquid with
odours of raspberry and ethanol. It is supplied in a

yellow 100ml glass bottle with plastic cap as
well as 2000ml plastic containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Cox Pharmaceutical Ltd
788-790 Finchley Road, London
NW11 7TJ, United Kingdom

Please read the Pack

reverse of this label before use.

HOW MUCH TO GIVE
DO NOT EXCEED THE STATED DOSE.

AGE

DOSAGE

CHILDREN 1 TO 6 YEARS
CHILDREN 3 MONTHS TO 1 YEAR
CHILDREN UNDER 3 MONTHS

One to two 5ml spoonfuls every 4 hours.
Half to one 5ml spoonful every 4 hours.
On doctors advice only.

NOT MORE THAN 4 DOSES IN ANY 24 HOUR PERIOD.
DO NOT EXCEED THE STATED DOSE.
IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR.

Manufacturer:
To Be Confirmed
PL 42671/0002

Date of last revision: Oct 2014

DO NOT STORE ABOVE 25ºC.
KEEP THE CONTAINER TIGHTLY CLOSED. STORE IN THE ORIGINAL CONTAINER.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Technical NON-Printed items:

Colour References:

Pantone
Blue
2728 C

Pantone
Red
186C

Pantone
Process
Black C

BRAILLE
Blind embossing
DO NOT PRINT

Please note: If this proof is not a press proof and it
cannot be judged for colour accuracy; it will be
representative only.

bilton by design

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.

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