COVONIA NIGHT TIME FORMULA

Active substance: DIPHENHYDRAMINE HYDROCHLORIDE

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22575207

NEW ADVICE FOR DRIVERS - SEE REVERSE

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Process Black

Futura

Portrait single ply front label

PANTONE 2685 C

Helvetica

Pack Size

a

Covonia Night Time Formula

Component

Braille Reads

150ml

PANTONE 2725 C

IG Code

22575207

PANTONE 485 C

Dimensions

90 x 50mm

PANTONE 7443 C

Proof No.

2

Date

Keyline (Does not print)

21.05.2014

Braille

22575207

PCP Header Box
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.

Operator

Approved by
Date

gill.kennedy

Artwork No 486062
Suf fix

CRN

11024

Reason for
Change

Addition of driving warnings at
the request of the MHRA

A

Issued by
Date

MHRA/IMB
submission Yes
required

If symptoms persist consult your doctor.
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 reach and sight
of children.
Active ingredients per 5ml:
dextromethorphan hydrobromide 6.65mg,
diphenhydramine hydrochloride 10mg.
Also contains: ethanol, glycerol (E422),
sorbitol (E420), sodium benzoate, maltitol
liquid, propylene glycol. Alcohol 7.3 vol%.
See reverse for full list.

Talk to your doctor if you have….

• Glaucoma • Difficulty passing urine • Prostate trouble
• A blocked intestine • Epilepsy • Heart problems
• A cough which lasts a long time • Or you are prone to allergies

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

• Alcohol • Cimetidine for stomach ulcers • Medicines for
depression or Parkinson’s disease (e.g. rasagiline, moclobenide,
venlafaxine) • Medicines for mental illness (e.g. haloperidol,
thioridazine) • Medicines for anxiety or to help you sleep
(e.g. diazepam) • Memantine for Alzheimer’s disease • Medicines
for irregular heartbeat (e.g. amiodarone, propafenone, quinidine,
beta blockers) • Antihistamines • Betahistine for vertigo or
histamine for some types of cancer • Strong pain killers
(e.g. codeine) • Medicine for a runny nose or to control the
bladder, or atropine used to treat eye problems.

Driving and using machines….

This medicine causes drowsiness and you should not drive or
operate machinery until the effects have worn off.
Turn Over

22576012

LOT, MAN &
EXP printed here

The medicine can affect your ability to drive as it may make P2
you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it
affects you.
• It is an offence to drive if this medicine affects your ability to
drive.
• However, you would not be committing an offence if:
° The medicine has been prescribed to treat a medical or dental
problem and
° You have taken it according to the instructions given by the
prescriber or in the information provided with this medicine and
° It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.

Pregnant or breastfeeding….

Ask your doctor or pharmacist for advice before using if you are
pregnant, might be pregnant or are breastfeeding. This medicine
should not be used unless the doctor has told you to do so.

Important ingredient information

• Contains maltitol liquid and sorbitol. If you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine • It contains
7.3 vol% of ethanol (alcohol), i.e. up to 870mg per dose,
equivalent to 22ml of beer or 9ml of wine per dose. Harmful for
those suffering from alcoholism. To be taken into account in
children and high risk groups such as patients with liver disease
or epilepsy.

2. Possible side effects

Like all medicines, Covonia Night Time Formula can have side
effects, although these don’t affect everyone.

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Important side effects. If you get any of these side effects
stop use immediately and see a doctor as soon as possible:
• Swelling of the lips, mouth, eyes or tongue • Difficulty breathing • Fits.
Other possible side effects: Drowsiness and lack of concentration
• Dizziness • Feeling excited or confused • Feeling depressed • Sleeping
problems • Headache • Muscle twitching • Trembling • Blurred vision
• Stomach upsets (e.g. feeling sick, being sick, diarrhoea) • Rash
• Skin blisters • Pins and needles • Dry mouth • Thick saliva • Low blood
pressure, palpitations or irregular heartbeat • Difficulty passing urine
• Blood or liver problems • Eye problems (glaucoma) • Sweating • Muscle
pain • Ringing in the ears • Hair loss. If you notice these or any other
side effects not listed, stop use and tell your doctor or pharmacist.

3. Further information

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 ingredients per 5ml are: dextromethorphan
hydrobromide 6.65mg, diphenhydramine hydrochloride 10mg.
The other ingredients are: ethanol, glycerol (E422), sorbitol (E420),
sodium benzoate, maltitol liquid, hydroxyethylcellulose, povidone
(E1202), saccharin sodium, capsicum tincture (capsicum oleoresin),
menthol, peppermint oil, anise oil, citric acid (E330), macrogol
cetostearyl ether, caramel (E150), blackcurrant flavour (containing
propylene glycol) and purified water.
What the medicine looks like

Covonia Night Time Formula is a brown syrupy liquid.
It is supplied in 150ml bottles.

This label was revised in May 2014
22576012

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 485597
Suf fix

CRN

11024

Reason for
Change

Addition of driving warnings at
request of the MHRA

B

Issued by
Date

MHRA/IMB
submission Yes
required

Print Free Area (Non-printing)
22576012

73 x 90mm

2

IG Code

Dimensions

Proof No.

Date

06.05.2014

Keyline (Non printing)
150ml

Process Black
Portrait Booklet Back Label

Helvetica LT
Pack Size

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 depression within
the last two weeks or are taking SSRIs for depression
• Shortage of breath • Liver problems • Porphyria • Asthma or a
cough which produces phlegm.

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1. Before you use this medicine

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Component

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

Peel where shown for further
precautions.

Covonia Night Time Formula contains dextromethorphan
which reduces the desire to cough and diphenhydramine (an
antihistamine) which dries up your runny nose and relieves
congestion.

MHRA Header Box

150ml

Covonia Night Time Formula is for night
time relief of the symptoms of dry coughs
and congestion from colds.
SHAKE THE BOTTLE. Take the solution
by mouth.
Adults, the elderly and children over
12 years: Take 3 x 5ml spoonfuls at
bedtime. Repeat after 6 hours if required.
Do not give to children under 12 years old.
DO NOT EXCEED THE STATED DOSE.
Do not take with any other cough and
cold medicine. Avoid alcoholic drink.

Covonia Night Time Formula

Do not store above 25°C.
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Protect from light.
MA holder and manufacturer
Thornton and Ross Ltd.,
Huddersfield, HD7 5QH, UK
PL 00240/0042 22576012
MA055/00503
COVONIA is a registered Trade Mark.

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22576012

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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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