BENYLIN CHILDRENS NIGHT COUGHS

Active substance: LEVOMENTHOL

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2 Before giving your child
this medicine

Children’s Night Coughs
6 - 12 YEARS

diphenhydramine, levomenthol
This medicine is used to help relieve the symptoms
of cough and congestion and also for hayfever and
other allergic conditions.
■ This medicine is for use by children aged 6-12 years.
■ Do not give your child this medicine:
■ There are some people who should not use this
medicine. To find out if your child is one of them see
section 2 c
■ If your child has ever had a bad reaction to any of
the ingredients. For the list of ingredients see section 6


c

Speak to your doctor:
■ If your child suffers from any of the conditions
mentioned in section 2. See section 2 c
■ If your child is taking any other medicines. See
section 2 c
■ Follow the dosage instructions carefully. See
section 3 c
Some children should not take this product. Follow
the instructions shown in the table carefully.
Now read this whole leaflet carefully before you use
this medicine. Keep the leaflet: you might need it again.


1 What the medicine is for
Benylin Children's Night Coughs is a medicine used
to relieve the symptoms of cough and congestion. It
also helps relieve runny nose and sneezing associated
with hayfever and other allergies. The liquid contains
diphenhydramine hydrochloride which is an antihistamine
that helps relieve coughing and dry secretions in the nose
and chest, and levomenthol which helps you breathe
more easily by relieving congestion.
The medicine is for use in children aged 6 to 12 years.

This medicine is suitable for most children but a few
children should not use it. If you are in any doubt, talk to
your doctor or pharmacist.

X Do not give your child this medicine…
If s/he has ever had a bad reaction to this
product or any of the ingredients.
■ If he suffers from prostate problems (difficulty with
passing water or needing to pass water often).
■ If s/he suffers from or has had closed angle
glaucoma (increased pressure in the eye).
■ If s/he is taking, or has taken in the last two
weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
■ If s/he is taking any other cough and cold
medicine.
■ If s/he is aged under 6 years old.
If any of these apply, get advice from a doctor or
pharmacist without using Benylin Children's Night
Coughs.


Talk to your doctor or pharmacist…
If your child suffers from liver or kidney
problems.
■ If your child has difficulty passing water
(urinary retention).
■ If your child has a persistent cough such as
occurs with asthma, has asthma, is suffering
from an asthma attack or a cough that
produces a lot of mucus (phlegm).
■ If your child is taking any other medicines containing
codeine (sometimes used as a pain killer).
■ If you have been told by your doctor that your
child has an intolerance to some sugars.
■ If your child is taking any other medicines,
including:
■ Antimuscarinic / anticholinergic drugs e.g.:
■ tricyclic antidepressants (drugs to treat mood
disorders).
■ atropine (used to treat some eye conditions
and occasionally bowel conditions).
■ CNS depressants e.g.:
■ barbiturates (a kind of sleeping tablet).
■ minor tranquillisers (drugs used to relax
muscles or decrease anxiety).


opioid analgesics (drugs used to relieve
pain e.g. codeine, tramadol, morphine).
antipsychotics (drugs used to treat mood
disorders).
If you are not sure about any of the medicines your
child is taking, show the bottle or pack to your
pharmacist.
If any of these bullet points apply now or in the
past, talk to a doctor or pharmacist.




If you are pregnant or breast-feeding
The following advice is included in case an
older child or adult is taking the medicine:
■ Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or breast-feeding.

Special warnings about this medicine
This product can make some people feel
drowsy, dizzy or have blurred vision. Make
sure that your child is not affected if he or
she is going to do anything where they need
to be alert. Be especially careful if the child
is taking another medicine which may also
cause drowsiness.
■ If an older child or adult is taking the
medicine remember that this product may
cause drowsiness, dizziness or blurred
vision. Do not drive or operate machinery if
you are affected. Avoid alcoholic drink.


Some of the ingredients can cause
problems
This medicine contains sorbitol 70% (non
crystalline). If you have been told by your
doctor that your child has an intolerance to
some sugars contact your doctor before taking
this medicinal product.
■ This medicinal product contains 5 vol %
ethanol (alcohol), i.e. up to 200 mg per
5 ml, equivalent to 5 ml beer, 2 ml wine per
5 ml. This can be harmful for those suffering
from alcoholism. To be taken into account in
pregnant or breast-feeding women, children
and high-risk groups such as patients with
liver disease or epilepsy.
■ This medicinal product contains 16.47 mg
sodium per 5 ml. To be taken in consideration
by patients on a controlled sodium diet.


turn over c

F307721 - Leaflet BENYLIN Children s Night Coughsv6.0.indd 1

05/01/10 12:10

3 How to use this
medicine
Check the table below to see how much
medicine to take.
For oral use only.
■ Do not use more than the stated dose shown below.


4 Possible side-effects

6 Further information

Benylin Children’s Night Coughs can have side-effects,
like all medicines, although these don’t affect everyone
and are usually mild.

What’s in this medicine?

If your child experiences any of the
following, stop using the medicine and
seek immediate help:
Allergic reactions including skin rashes (which may
be severe and include blistering and peeling of the
skin) and itching.
■ Rarely people can experience fits.
■ Rarely abnormal blood test results for liver
function.


i

Children under 6 years
Do not give to children under 6 years old.

i

Children 6 to 12 years

Age

Dose

Children
6 – 12 years

Two 5 ml spoonfuls
every 6 hours

Do not give more than 4 doses in 24 hours.
Do not use for more than 5 days without the
advice of a doctor.
■ Do not use to sedate a child.
■ If symptoms persist or worsen, talk to your
doctor or pharmacist.



If your child experiences any of the
following, stop using the medicine and
talk to your doctor:
Rarely people can have an irregular heartbeat or an
increased awareness of the heartbeat (palpitations).
■ Sleep disturbances.


Other effects that may occur include:

If anyone has too much, contact a doctor or your
nearest Accident and Emergency Department
(Casualty) taking this leaflet and pack with you.

Commonly: drowsiness, including some difficulty
performing tasks.
■ Commonly: headache, upset stomach, difficulty
in passing urine, stimulation, blurred vision, dry
mouth, thickened mucus.
■ Rarely: low blood pressure, tremor, shakiness,
slurred speech, dizziness, confusion, depression.
■ Rarely: blood disorders.
If your child experiences any side-effects not included
in this leaflet, or you are not sure about anything,
talk to your doctor or pharmacist.

If you forget to give the medicine

5 Storing this medicine

You should only give this medicine as required
following the dosage instructions above carefully. If
you forget to give a dose, give the next dose when
needed provided that the last dose was at least
6 hours ago. Do not give a double dose.

Store below 30ºC.
Keep the product out of the reach and sight of children.
Do not use your medicine after the date shown as an
expiry date on the packaging.
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.

If anyone has too much

F307721 - Leaflet BENYLIN Children s Night Coughsv6.0.indd 2



The active ingredients in 5 ml of Benylin
Children's Night Coughs are: 7 mg Diphenhydramine
hydrochloride and 0.55 mg Levomenthol.
Other ingredients are: Sorbitol solution, glycerol,
ethanol, sodium carboxymethylcellulose, sodium
citrate, citric acid monohydrate, sodium benzoate (E211),
sodium saccharin, raspberry essence and purified water.

What the medicine looks like
Benylin Children's Night Coughs is a clear colourless
syrup, available in 125 ml glass bottles.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
This leaflet was revised January 2010.
Benylin is a registered trade mark.

7 Information about
treating cough and cold
in children
It's normal for children to get 8 or more colds in a
year. Because colds are caused by viruses, not bacteria,
antibiotics don't help.
Here are simple steps to help your child who has a cough
or cold.
■ If they are hot/feverish: Increase the amount
of fluid your child normally drinks. Lower their
temperature with a paracetamol or ibuprofen
medicine which has doses for children.
■ For coughs: Coughing serves a purpose, it helps
clear phlegm and mucus. Give the child plenty of
warm clear fluids to drink.
■ To help with breathing: Plain saline nose drops /
sprays can help with blocked noses.
F307721
10/0007

05/01/10 12:10

BENYLIN CHILDREN'S NIGHT COUGHS 125ML

UK

Component Number

Component type

Dimensions

Code descriptif générique

Version

F307721

Notice bobine / Rolled Leaflet

160 x 210 mm

NOTC010

V6.0

Safety code

Job Bag Number

DATA MATRIX
FRONT

10/0007
Colours

REAR

PMS 2597

PMS 2597

PMS 2735

PMS 2735

F307721 - Leaflet BENYLIN Children s Night Coughsv6.0.indd 3

05/01/10 12:10

2 Before giving your child
this medicine
This medicine is suitable for most children but a few
children should not use it. If you are in any doubt, talk to
your doctor or pharmacist.

Night Coughs
Diphenhydramine, Levomenthol

This medicine is used to help relieve the symptoms
of cough and congestion and also for hayfever and
other allergic conditions.
■ This medicine is for use by children aged 6-12 years.
■ Do not give your child this medicine:
■ There are some people who should not use this
medicine. To find out if your child is one of them see
section 2 c
■ If your child has ever had a bad reaction to any of the
ingredients. For the list of ingredients see section 6 c
■ Speak to your doctor:
■ If your child suffers from any of the conditions
mentioned in section 2. See section 2 c
■ If your child is taking any other medicines. See
section 2 c
■ Follow the dosage instructions carefully. See
section 3 c
Some children should not take this product. Follow the
instructions shown in the table carefully.
Now read this whole leaflet carefully before you use
this medicine. Keep the leaflet: you might need it again.


1 What the medicine is for
Benylin Children's Night Coughs is a medicine used
to relieve the symptoms of cough and congestion. It
also helps relieve runny nose and sneezing associated
with hayfever and other allergies. The liquid contains
diphenhydramine hydrochloride which is an antihistamine
that helps relieve coughing and dry secretions in the nose
and chest, and levomenthol which helps you breathe
more easily by relieving congestion.
The medicine is for use in children aged 6 to 12 years.

X Do not give your child this medicine…
If s/he has ever had a bad reaction to this
product or any of the ingredients.
■ If he suffers from prostate problems (difficulty with
passing water or needing to pass water often).
■ If s/he suffers from or has had closed angle
glaucoma (increased pressure in the eye).
■ If s/he is taking, or has taken in the last two
weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
■ If s/he is taking any other cough and cold
medicine.
■ If s/he is aged under 6 years old.
If any of these apply, get advice from a doctor or
pharmacist without using Benylin Children's Night
Coughs.

opioid analgesics (drugs used to relieve
pain e.g. codeine, tramadol, morphine).
antipsychotics (drugs used to treat mood
disorders).
If you are not sure about any of the medicines your
child is taking, show the bottle or pack to your
pharmacist.
If any of these bullet points apply now or in the
past, talk to a doctor or pharmacist.






Talk to your doctor or pharmacist…
If your child suffers from liver or kidney
problems.
■ If your child has difficulty passing water
(urinary retention).
■ If your child has a persistent cough such as
occurs with asthma, has asthma, is suffering
from an asthma attack or a cough that
produces a lot of mucus (phlegm).
■ If your child is taking any other medicines containing
codeine (sometimes used as a pain killer).
■ If you have been told by your doctor that your
child has an intolerance to some sugars.
■ If your child is taking any other medicines,
including:
■ Antimuscarinic / anticholinergic drugs e.g.:
■ tricyclic antidepressants (drugs to treat mood
disorders).
■ atropine (used to treat some eye conditions
and occasionally bowel conditions).
■ CNS depressants e.g.:
■ barbiturates (a kind of sleeping tablet).
■ minor tranquillisers (drugs used to relax
muscles or decrease anxiety).


If you are pregnant or breast-feeding
The following advice is included in case an
older child or adult is taking the medicine:
■ Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or breast-feeding.

Special warnings about this medicine
This product can make some people feel
drowsy, dizzy or have blurred vision. Make
sure that your child is not affected if he or
she is going to do anything where they need
to be alert. Be especially careful if the child
is taking another medicine which may also
cause drowsiness.
■ If an older child or adult is taking the
medicine remember that this product may
cause drowsiness, dizziness or blurred vision.
Do not drive or operate machinery if you are
affected. Avoid alcoholic drink.


Some of the ingredients can cause
problems
This medicine contains sorbitol 70% (non
crystalline). If you have been told by your
doctor that your child has an intolerance to
some sugars contact your doctor before taking
this medicinal product.
■ This medicinal product contains 5 vol %
ethanol (alcohol), i.e. up to 200 mg per
5 ml, equivalent to 5 ml beer, 2 ml wine per
5 ml. This can be harmful for those suffering
from alcoholism. To be taken into account in
pregnant or breast-feeding women, children
and high-risk groups such as patients with
liver disease or epilepsy.
■ This medicinal product contains 16.47 mg
sodium per 5 ml. To be taken in consideration
by patients on a controlled sodium diet.


turn over c

F309269 - Leaflet BENYLIN CHILD NIGHT COUGHS 125MLv7.5.indd 1

26/11/13 14:17

3 How to use this
medicine
Check the table below to see how much
medicine to take.



For oral use only.
Do not use more than the stated dose shown below.

4 Possible side-effects

6 Further information

Benylin Children’s Night Coughs can have side-effects, like
all medicines, although these don’t affect everyone and are
usually mild.

What’s in this medicine?

If your child experiences any of the
following, stop using the medicine and
seek immediate help:
Allergic reactions including skin rashes (which may be
severe and include blistering and peeling of the skin)
and itching.
■ Rarely people can experience fits.
■ Rarely abnormal blood test results for liver function.


i

Children under 6 years
Do not give to children under 6 years old.

i

Children 6 to 12 years
Age

Dose

Children
6 – 12 years

Two 5 ml spoonfuls
every 6 hours

Do not give more than 4 doses in 24 hours.
Do not use for more than 5 days without the
advice of a doctor.
■ Do not use to sedate a child.
■ If symptoms persist or worsen, talk to your
doctor or pharmacist.



If anyone has too much
If anyone has too much, contact a doctor or your
nearest Accident and Emergency Department
(Casualty) taking this leaflet and pack with you.

If you forget to give the medicine
You should only give this medicine as required
following the dosage instructions above carefully. If
you forget to give a dose, give the next dose when
needed provided that the last dose was at least
6 hours ago. Do not give a double dose.

F309269 - Leaflet BENYLIN CHILD NIGHT COUGHS 125MLv7.5.indd 2

If your child experiences any of the
following, stop using the medicine and talk
to your doctor:
Rarely people can have an irregular heartbeat or an
increased awareness of the heartbeat (palpitations).
■ Sleep disturbances.


Other effects that may occur include:
Commonly: drowsiness, including some difficulty
performing tasks.
■ Commonly: headache, upset stomach, difficulty in
passing urine, stimulation, blurred vision, dry mouth,
thickened mucus.
■ Rarely: low blood pressure, tremor, shakiness, slurred
speech, dizziness, confusion, depression.
■ Rarely: blood disorders.


Reporting of side-effects
If you get any side-effects, talk to your doctor, pharmacist
or nurse. This includes any possible side-effects not listed in
this leaflet. You can also report side-effects directly via the
Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side-effects you can help provide more
information on the safety of this medicine.

5 Storing this medicine
Store below 30ºC.
Keep the product out of the reach and sight of children.
Do not use your medicine after the date shown as an
expiry date on the packaging.
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.

The active ingredients in 5 ml of Benylin Children's
Night Coughs are: 7 mg Diphenhydramine hydrochloride
and 0.55 mg Levomenthol.
Other ingredients are: Sorbitol solution (E420), glycerol,
ethanol, sodium carboxymethylcellulose, sodium
citrate, citric acid monohydrate, sodium benzoate (E211),
sodium saccharin, raspberry essence and purified water.

What the medicine looks like
Benylin Children's Night Coughs is a clear colourless syrup,
available in 125 ml glass bottles.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
This leaflet was revised November 2013.
Benylin is a registered trade mark.

7 Information about
treating cough and cold
in children
It's normal for children to get 8 or more colds in a
year. Because colds are caused by viruses, not bacteria,
antibiotics don't help.
Here are simple steps to help your child who has a cough
or cold.
■ If they are hot/feverish: Increase the amount
of fluid your child normally drinks. Lower their
temperature with a paracetamol or ibuprofen
medicine which has doses for children.
■ For coughs: Coughing serves a purpose, it helps
clear phlegm and mucus. Give the child plenty of
warm clear fluids to drink.
■ To help with breathing: Plain saline nose drops /
sprays can help with blocked noses.
F309269
12-0114

26/11/13 14:17

UK

BENYLIN CHILDREN'S NIGHT COUGHS 125ML
F309269

Notice bobine / Rolled Leaflet

DATA MATRIX

12-0114

PMS 485

JNJ

V7.5

NOTC010

PMS 485

PMS 2735

160 x 210 mm

PMS 2735

F309269 - Leaflet BENYLIN CHILD NIGHT COUGHS 125MLv7.5.indd 3

26/11/13 14:17

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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