COVONIA ORIGINAL BRONCHIAL BALSAM

Active substance: MENTHOL

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21454816

NEW ADVICE FOR DRIVERS - SEE REVERSE

MHRA Header Box
Colours Used

Fonts Used

Product
Title

Covonia Original Bronchial Balsam
Syrup

Process Black

Futura

Component

Portrait single ply front label

PANTONE 356 C

Helvetica

Pack Size

150ml

PANTONE 201 C

IG Code

21454816

PANTONE 485 C

Dimensions

90 x 50mm

PANTONE 712 C

Proof No.

3

Date

Keyline (Does not print)

23.07.2014

Braille

21454816

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 526937
Suf fix

CRN

11026

Reason for
Change

Addition of driving warnings at
the request of the MHRA

A

Issued by
Date

MHRA/IMB
submission Yes
required

depression within the last two weeks

• Shortage of breath • Liver problems • An asthma attack
• A persistent cough or one which produces phlegm
• Or are under 12 years.

Talk to your doctor if you have....
Talk to your doctor or pharmacist if you are
taking....

• Cimetidine for stomach ulcers

Pregnant or breastfeeding....

Ask your doctor or pharmacist for advice before using if you
are pregnant, might be pregnant or are breastfeeding.

Driving and using machines....

This medicine normally works without causing drowsiness,
but care should be taken initially as in rare cases drowsiness
may occur. If you are affected do not drive or operate
machinery.

Turn Over

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LOT, MAN & EXP
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P3
The medicine can affect your ability to drive as it may make P2 3. Further information
you sleepy or dizzy.
If you accidentally take too much see a doctor straight
• Do not drive while taking this medicine until you know
away. Take the pack with you to show which medicine you have
how it affects you.
swallowed.
• It is an offence to drive if this medicine affects your ability
• Do not use after the expiry date. The expiry date refers
to drive.
to the last day of that month.
• However, you would not be committing an offence if:
• Return any unused medicine to the pharmacy for disposal.
The medicine has been prescribed to treat a medical or
°
The active ingredients per 5ml are: dextromethorphan
dental problem and
hydrobromide 7.5mg, menthol 2.5mg.
° You have taken it according to the instructions given by the
The other ingredients are: ethanol, glycerol (E422), capsicum
prescriber or in the information provided with this medicine
tincture (capsicum oleoresin), peppermint oil, anise oil, citric
and
acid (E330), macrogol cetostearyl ether, caramel (E150), diethyl
It was not affecting your ability to drive safely.
°
ether, cineole, chloroform, sucrose and purified water.
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.
What the medicine looks like
Covonia Original Bronchial Balsam Syrup is a brown syrupy liquid.
Important ingredient information
It is supplied in 150ml bottles.
• Contains 3.07g of sucrose per 5ml dose. This should be taken into
This label was revised in August 2014
account in people with diabetes. If you have an intolerance to
some sugars, contact you doctor before taking this medicine.
• It contains small amounts of ethanol (alcohol), less than 100mg per
10ml dose.

2. Possible side effects

22579511

Approved by
Date

Artwork No 526944
Suf fix

CRN

11026 & 11146

Reason for
Change

Addition of driving warnings at
the request of the MHRA resulting
in the RMS having to change

A

Issued by
Date

MHRA/IMB
submission Yes
required

Print Free Area (non-printing)
22579511

73 x 90mm

3

Dimensions

Proof No.

Date

23.07.2014

Keyline (non-printing)
150ml

Process Yellow

Process Black

IG Code

Do not use the medicine if you have....

• An allergy to any of the ingredients listed in section 3
• Taken MAOIs (monoamine oxidase inhibitors) for

gill.kennedy

Pack Size

• A history of asthma.

Operator

Portrait peelable booklet back label

If symptoms persist consult your doctor.
Do not store above 25°C.
This medicine can make you feel sleepy.
Do not drive while taking this medicine
until you know how it makes you feel.
See the leaflet inside for more
information.
Keep out of the sight and reach of
children.
Active ingredients per 5ml:
dextromethorphan hydrobromide 7.5mg,
menthol 2.5mg.
Also contains: ethanol, glycerol (E422),
sucrose. Alcohol 0.18 vol%. Sucrose
3.07g per 5ml.
See reverse for full list.

P1

1. Before you use this medicine

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Component

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Covonia Original Bronchial Balsam Syrup contains
dextromethorphan which reduces the desire to cough and
menthol which relieves irritation, reduces congestion and
helps you breathe more easily.

Like all medicines, Covonia Original Bronchial Balsam Syrup
can have side effects, although these don’t affect everyone.
Possible side effects: drowsiness • dizziness • sickness or
feeling sick • constipation • stomach discomfort.
If you notice these or any other side effects not listed, stop use
and tell your doctor or pharmacist.
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.

Covonia Original Bronchial Balsam
Syrup

IMPORTANT: Peel here & read all text inside BEFORE use.

Covonia Original Bronchial Balsam
Syrup is for relief of the symptoms of dry
coughs from colds and bronchitis.
SHAKE THE BOTTLE VIGOROUSLY.
Take the solution by mouth.
Adults, the elderly and children over
12 years: Take 2 x 5ml spoonfuls every
4 hours if required.
Do not give to children under 12 years
old unless your doctor tells you to.
DO NOT EXCEED THE STATED DOSE.
Talk to your doctor before use if you
have a history of asthma.

MHRA Header Box

150ml

Peel where shown for further
precautions

Product
Title

5 011309 020014
MA holder and manufacturer P
Thornton and Ross Ltd.,
Huddersfield, HD7 5QH, UK
PL 00240/5033R 22579511
MA055/00501
COVONIA is a registered Trade Mark.

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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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