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CARE PHOLCODINE 5MG/5ML ORAL SOLUTION SUGAR FREE

Active substance(s): PHOLCODINE

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Braille

65 x 170mm

1

Dimensions

Proof No.

Date

21.10.2014

Process Black
23005511
IG Code

Keyline (Does not print)

Process Yellow
200ml

OCRB
Process Magenta

Process Cyan

Colours Used

Pack Size

Important ingredient information

• This medicine contains small amounts of ethanol
(alcohol), less than 100mg per 10ml dose.
• It also contains sodium parahydroxybenzoates and
amaranth dye which may cause allergic reactions
(possibly delayed).

Landscape peelable label

• Medicine for high blood pressure, e.g. ACE
inhibitors, beta blockers.
• Diuretics, which help remove fluid from the
body, e.g. furosemide, hydrochlorothiazide.
• Medicines used to treat sleeplessness, anxiety
and schizophrenia.
• Alcohol or tranquillisers.
• Pain killers, e.g. morphine.
• Or are having surgery, as muscle relaxants used
may react with this medicine.

Driving and using machines....

This medicine may cause drowsiness. If you are affected
do not drive or operate machinery.

Component

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

• An allergy to any of the ingredients listed in
section 3.
• Liver disease.
• Shallow breath or breathing difficulties.
• An asthma attack.
• Taken MAOIs (monoamine oxidase inhibitors)
for depression within the last two weeks.
• Or in children under 12 years old.

are taking....

If you use it when breastfeeding, pholcodine in this
medicine will be present in small amounts in your milk.

Care Pholcodine 5mg/5ml Oral Solution
Sugar Free

Do not store above 25°C.
Keep out of the sight and reach of children.
Manufactured by the licence holder
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
PL 00240/0101
PIP: 296-4625
23005511

Product
Title

Peel where shown for full list of
ingredients.

This medicine contains pholcodine, which reduces • A cough for a long time or a cough which
produces lots of phlegm.
the desire to cough. It relieves dry coughs which
are without phlegm.
Talk to your doctor or pharmacist if you

1. Before you use this medicine

Fonts Used

Active ingredient per 5ml: pholcodine 5mg.
Also contains amongst other ingredients:
ethanol, glycerol (E422), sodium
parahydroxybenzoates (E215, E217, E219),
amaranth dye (E123). Alcohol 1.2 vol%.

MHRA Header Box

For symptomatic relief of dry or irritating
coughs.
Take the solution by mouth.
Adults, the elderly and children over
12 years: Take 1 or 2 x 5ml spoonfuls three
or four times a day.
Do not give more than 4 doses in 24 hours.
Do not give to children under 12 years old.
DO NOT EXCEED THE STATED DOSE.
Do not take with other cough and cold
medicines.
If symptoms persist consult your doctor.

Peel where shown for further
precautions.

5 011309 015515

IMPORTANT: Peel this label
at corner and read BEFORE
use. Do not tear off, re-fix for
future use.

Helvetica LT

BN, MAN & EXP
overprint area

Talk to your doctor or pharmacist if you
Pregnant or breastfeeding....
have....
Ask your doctor or pharmacist for advice

• Kidney problems.
• Liver problems.
• A history of asthma or other breathing problems
including bronchitis.

Artwork No 537244
Suf fix

CRN

11606

Reason for
Change

Addition of reporting of side
effects statement

B

Issued by
Date

MHRA/IMB
submission Yes
required

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Approved by
Date

Braille Warning! Chesapeake cannot accept
responsibility for any errors in this proof after
approval by the customer.
Whilst extreme care is taken in the setting of Braille,
the customer must take the final responsibility for
its accuracy.
There is no single European Braille authority and
there are many different Braille formats in existence,
with country specific characters.
This Braille is set to the Marburg Medium format
unless you have requested otherwise.
When you sign this proof you are signifying full
approval of the Braille text and specification.

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PCP Header Box

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23005511

jade.cerff/gill.kennedy

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If you accidentally take too much see a
doctor straight away. Take the pack with you to
show which medicine you have swallowed.
• Do not use after the expiry date. The expiry date
refers to the last day of that month.
• Return any unused medicine to the pharmacy
for disposal.
The active ingredient per 5ml is: pholcodine 5mg.

23005511

Operator

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3. Further information

no.

• Getting excited.
• Confusion.
• Being sick.
• Rash.
• Failure to cough up phlegm.

Care Pholcodine Oral Solution Sugar Free is a thick red
liquid which smells of menthol and aniseed.
it is supplied in 200ml bottles.
This label was last revised in October 2014

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• Feeling sick.
• Constipation.
• Dizziness.
• Drowsiness.

What the medicine looks like

Braille reads:

Other possible side effects are:

The other ingredients are: citric acid monohydrate (E330),
sodium methyl, ethyl and propyl parahydroxybenzoates
(E215, E219, E217), glycerol (E422), ethanol, amaranth dye
(E123), saccharin sodium, carmellose sodium, levomenthol,
condensed milk flavour, aniseed flavour and purified water.

a

If you notice these or any other side effects, stop
use and tell your doctor or pharmacist. They will
tell you what to do.
Reporting of side effects
If you get any side effects, talk to your doctor,
Important side effects:
pharmacist or nurse. This includes any possible
If you think you have any of the following side
side effects not listed in this leaflet. You can also
effects or symptoms, stop using this medicine
report side effects directly via the Yellow Card
immediately and see a doctor as soon as possible.
Scheme at: www.mhra.gov.uk/yellowcard
• Allergic reactions which cause difficulty in
By reporting side effects you can help provide
breathing, fever, swelling of the mouth, lips or
more information on the safety of this medicine.
skin, severe rashes and itching.
Like all medicines, Care Pholcodine Oral Solution
Sugar Free can have side effects, although these
don’t affect everyone.

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2. Possible side effects

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23005511

before using this medicine if you are pregnant,
might be pregnant or are breastfeeding.
Care Pholcodine Oral Solution Sugar Free should
not be used in pregnancy unless the doctor has
told you to do so.

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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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