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6 mm

1 What the medicine is for

medicine is used to provide relief from
blocked nose and other symptoms associated
with colds, flu and allergies.
I This medicine is for use by adults and children
aged 12 years and over.
I Do not use this medicine:
I There are some people who should not take this
medicine. To find out if you are one of them see
section 2 c
I If you have ever had a bad reaction to any of
the ingredients. For the list of ingredients see
section 6 c
I Speak to your doctor:
I If you suffer from any of the conditions
mentioned in section 2. See section 2 c
I If you are taking any other medicines.
See section 2 c
I Follow the dosage instructions carefully.
See section 3 c
Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might
need it again.


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

X Do not use this medicine…
If you have ever had a bad reaction (e.g. rash,
swelling of the face and throat, difficulty
breathing) to any of the ingredients.
I If you have very high blood pressure or
severe heart disease.
I If you are taking, or have taken in the last two
weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs) or
linezolid (an antibacterial agent).
If any of these apply to you, get advice from a
doctor or pharmacist without using
Sudafed 12 Hour Decongestant Tablets.

If any of these bullet points apply to you now or
in the past, talk to a doctor or pharmacist.


If you are pregnant or breast-feeding:

Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or breast-feeding.

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I This

If you suffer from liver or kidney problems.
If you have heart disease or high blood
I If you have diabetes.
I If you have an overactive thyroid gland.
I If you have glaucoma (increased pressure in
the eye).
I If you have prostate problems (difficulty with
passing water or needing to pass water often).
I If you are taking any other medicines, including:
I Antihypertensives (drugs used to treat high
blood pressure such as, guanethidine,
methyldopa, alpha and beta blockers and
ergot alkaloids.
I Sympathomimetic drugs (stimulants or
appetite suppressants and drugs used to
treat congestion and asthma, this includes
other medicines containing pseudoephedrine).
I Tricyclic antidepressants (used to treat
mood disorders).
If you are not sure about any of the
medicines you are taking, show the bottle or
pack to your pharmacist.

Sudafed 12 Hour Decongestant Tablets is a medicine
which is used to provide relief from blocked nose and
other symptoms associated with colds, flu and
allergies. The tablets contain pseudoephedrine
hydrochloride, which is a decongestant that relieves
nasal and sinus congestion. The pseudoephedrine in
the tablets is slowly released over 12 hours to provide
relief from your symptoms.
This medicine is for use in adults and children aged
12 years and over.

spot = 12 x 2 centered in
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Pseudoephedrine hydrochloride

Talk to your doctor or pharmacist...

Distance between cutted line/middel of the spot = 83.6 mm

12 Hour


Barcodes placed at 14 mm
Hight for bars : 10 mm

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3 How to take this
Check the table that follows to see how
much medicine to take.
For oral use only.
Do not take more than the stated dose shown.
I Take with a glass of water. Swallow the tablet
whole without chewing.


Children under 12 years
Do not give to children under 12 years old.


Adults and children aged 12 years
and over



Adults and
children aged 12
years and over

1 tablet every 12 hours



Leave at least 12 hours between doses.
Do not take more than 2 tablets in 24 hours.

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


If you forget to take the medicine
If you forget to take a dose, take the next dose
when needed provided that the last dose was
taken at least 12 hours ago.
Do not take a double dose.

4 Possible side-effects

6 Further information

Sudafed 12 Hour Decongestant Tablets can have
side-effects, like all medicines, although these don't
affect everyone and are usually mild.

What’s in this medicine?

If you experience any of the following,
stop using this medicine and talk to
your doctor:
A few people have had hallucinations, but
this is rare.
I Occasionally people get skin rashes that are
sometimes itchy.
I A few men, especially men with prostate
problems, may have trouble passing water.

Other effects which may occur include:
Restlessness, having trouble getting to sleep
or bad dreams.
If you experience any side-effects not included in
this leaflet or are not sure about anything, talk to
your doctor or pharmacist.

5 Storing this medicine
Do not store above 25ºC.
Keep dry.
Protect from light.
Keep the product out of the reach and sight
of children.
Do not use after the end of the month 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 ingredient in Sudafed 12 Hour
Decongestant Tablets is: Pseudoephedrine
hydrochloride 120 mg per tablet.
Other ingredients are: Hypromellose (E464),
magnesium stearate, microcrystalline cellulose
(E460), povidone, titanium dioxide (E171),
polyethylene glycol, carnauba wax and purified
water. Printed ink: Shellac, FD & C blue #1
aluminium lake and propylene glycol.

What the medicine looks like
Sudafed 12 Hour Decongestant Tablets are white,
modified-release, elongated tablets. They are
available in packs of 6 tablets.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen Cilag S.A., Domaine de
Maigremont, 27100 Val de Reuil, France.
This leaflet was revised August 2010.
Sudafed 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.