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COVONIA DRY COUGH SUGAR FREE FORMULA

Active substance(s): PHOLCODINE

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Transcript
OUGH
F OR M U L A
Pholcodine
Ph
Pho
odine
ne 5mg/5ml
5

An or
oral liquid
liqu ffor
or the
th
t
elief off troublesome
trou eso
esom
relief
ry or irritating
itatin coughs
c
coug
dry

24785302

SUGAR
S
G AR FREE
F EE
AL OHOL
OH FREE
RE
REE
ALCOHOL

NEW FORMULA

MHRA Header Box
Product
Title

Covonia Dry Cough Sugar Free Formula

Component
Pack Size
IG Code

Colours Used

Fonts Used

Process Black

Braille BQ

Portrait single ply front label

PANTONE 485 C

FS Ingrid

150ml

PANTONE 2975 C

Garamond itcT

24785302

PANTONE 2995 C

Dimensions

90mm x 50mm

PANTONE 300 C

Proof No.

3

Date

12.11.2015

Keyline (Does not print)
Braille

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covonia dry
cough sugar
free formula

Braille reads:

When you sign this proof you are signifying full approval of
the Braille text and specification.

This Braille is set to the Marburg Medium format unless you
have requested otherwise.

There is no single European Braille authority and there are
many different Braille formats in existence, with country
specific characters.

Whilst extreme care is taken in the setting of Braille, the
customer must take the final responsibility for its accuracy.

Braille Warning! MPS cannot accept responsibility for any
errors in this proof after approval by the customer.

MA holder and manufacturer P
Thornton and Ross Ltd.,
Huddersfield,
HD7 5QH, UK.
PL 00240/0353 24786103
COVONIA is a registered
Trade Mark.

G
L
U
E

G
L
U
E

150ml

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

Covonia Dry Cough Sugar Free
Formula is an oral liquid for the
symptomatic relief of dry or irritating
coughs.
SHAKE THE BOTTLE. Take the
solution by mouth.
Adults, the elderly and children
over 12 years:
Take one or two 5ml spoonfuls,
three or four times a day. Do not give
more than 4 doses in 24 hours.
DO NOT EXCEED THE STATED DOSE.
Do not give to children under 12
unless your doctor tells you to.
Do not take with other cough and
cold medicines.
If symptoms persist consult your
doctor.
Do not store above 25°C.
Keep out of the sight and reach of
children.
Peel where shown for further
precautions.
Active ingredient per 5ml:
pholcodine 5mg.
Also contains amongst other
ingredients: glycerol (E422), sodium
parahydroxybenzoates (E215, E217,
E219).
See reverse for full list.

This product contains pholcodine,
o
which reduces
e dry coughs which
the desire to cough. It relieves
are without phlegm.

P1

1. Before you use this medicine
m
Do not use the medicine
n if you or your
child have….
• An allergy to any of the ingredients
g
listed in section 3.
r
• Liver disease • Shallow breath
or breathing
m or chest infections for a
difficulties • Chest problems
a
ac
long time • An asthma attack.
• Taken MAOI’s (monoaminee oxidase inhibitors) for
t weeks.
tw
depression within the last two
e old.
• Or your child is under 12 yyears

G
L
U
E

Talk to your doctor if you
o or your child have….
• Kidney problems • Liver problems.
roo
e breathing problems
• A history of asthma or other
including bronchitis.
• A cough for a long time or a cough which produces
lots of phlegm.

Talk to your doctor or pharmacist
ph
if you or your
child are taking....
• Medicine for high blood pressure,
ree
e.g. ACE inhibitors,
beta blockers.
ov water from the body,
• Diuretics, which help remove
or
e.g. furosemide, hydrochlorothiazide.
ee
• Medicines used to treat sleeplessness,
anxiety and
schizophrenia.
• Alcohol or tranquillisers.
• Pain killers, e.g. morphine..
• Or are having surgery, as m
muscle relaxants used may
react with this medicine.
Turn Over

24786103

LOT, MAN & EXP
overprint area

P2
Pregnant or breastfeeding….
d
Ask your doctor or pharmacist
c for advice before using
g
this medicine if you are pregnant,
might be pregnant or
di
are breastfeeding. This medicine
should not be used
yo to do so.
unless the doctor has told you
edd
If you use it when breastfeeding,
pholcodine in this
s
medicine will be present in small
amounts in your milk.

Driving and using machines….
ch
This medicine may cause drowsiness.
rro
If you are
err machinery.
affected do not drive or operate

Important ingredient information
n
• This medicine contains sodium
d
parahydroxybenzoates
which may cause allergic rre
reactions (possibly delayed).

2. Possible side effectss
Like all medicines, Covonia Dry
D Cough Sugar Free
ct although these don’t
Formula can have side effects,
affect everyone.

Important side effects
If you get any of these side eeffects stop use
o as soon as possible.
immediately and see a doctor
a
• Allergic reactions which cause
difficulty in breathing
u lips or skin • severe
• fever • swelling of the mouth,
rashes and itching.

ctt are:
Other possible side effects
• Feeling or being sick • Constipation
n
• Dizziness
tee or confused • Rash
• Drowsiness • Feeling excited
m
• Failure to cough up phlegm.
o
If you notice these or any other
side effects not listed
t or pharmacist.
stop use and tell your doctor

P3
If you get any side effects, talk
a to your doctor, pharmacist or
s
nurse. This includes any possible
side effects not listed in
poo side effects directly via the
this leaflet. You can also report
w
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects youu can help provide more
information on the safety of tthis medicine.

Reporting of side effects

3. Further information
If you accidentally takee too much see a doctor straight
away. Take the pack with youu to show which medicine you
have swallowed.
• Do not use after the expiryy date. The expiry date refers to
the last day of that month.
n to the pharmacy for disposal.
• Return any unused medicine
The active ingredient per 55ml is: pholcodine 5mg.
The other ingredients are:
e: citric acid monohydrate (E330),
yll parahydroxybenzoates (E215,
sodium methyl, ethyl, propyl
2)) saccharin sodium, xanthan
E217, E219), glycerol (E422),
) cough mixture flavour
gum (E415), caramel (E150),
a purified water.
(contains propylene glycol) and

What the medicine looks llike
Covonia Dry Cough Sugar Free
r Formula is a thick brown
h
liquid which smells of menthol.
e
It is supplied in 150ml bottles.

This label was last revised
ed in November 2015

24786103

MHRA Header Box
Product
Title

Covonia Dry Cough Sugar Free Formula

Component
Pack Size

Colours Used

Fonts Used

Process Yellow

Helvetica

Portrait Booklet Back Label

Process Black

Helvetica LT

150ml

Keyline (non-printing)
Text free area (non-printing)

IG Code

24786103

Dimensions

73mm x 90mm

Proof No.

2

Date

10.11.2015

24786103

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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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