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12 mm

6 mm

6 mm

Diphenhydramine, Paracetamol & Pseudoephedrine
I This

medicine is used to relieve the symptoms of cold
and flu.
I This medicine is for use by adults and children aged
12 years and over.
I This pack contains 2 different coloured tablets, for use
at different times of the day. Read the leaflet carefully to
ensure that you take the correct tablet at the appropriate
time of day.
I The white tablets contain paracetamol and
pseudoephedrine and are for daytime use.
I The blue tablets contain paracetamol and
diphenhydramine and are for night-time use only.
I Follow the dosage instructions carefully. There
are different tablets for day and night-time doses. See
section 3 c
I Do not use this medicine:
I There are some people who should not use 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
Now read this whole leaflet carefully before you use this
medicine. Keep the leaflet: you might need it again.

The white daytime tablets contain paracetamol, an
analgesic and antipyretic which helps to relieve pain and
fever and pseudoephedrine hydrochloride, a decongestant
which unblocks stuffy noses.
The blue night-time tablets contain paracetamol and
diphenhydramine hydrochloride, an antihistamine which
helps clear catarrh and so aids sleep.
This medicine is for use in adults and children aged over
12 years.

2 Before taking this
This medicine is suitable for most adults and children
aged over 12 years but a few people should not use it.
If you are in any doubt, talk to your doctor or

X Do not use this medicine…
If you have very high blood pressure or severe
heart disease.
I If you have ever had a bad reaction to paracetamol
or any of the other ingredients.
I If you are taking any other medicines containing
paracetamol or a decongestant.
I If you are taking, or have taken in the last two
weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
I If you are pregnant or breast-feeding.
If any of these apply to you, get advice from a
doctor or pharmacist without using Sudafed
Decongestant & Pain Tablets.


Talk to your doctor or pharmacist…
If you have liver or kidney problems.
If you have heart disease or mild to moderate high
blood pressure.
I If you have diabetes.
I If you have an overactive thyroid gland.
I If you have glaucoma (increased pressure in the eye).

spot = 12 x 2 centered in
the margin of 14 mm

Sudafed Decongestant & Pain Tablets are used for the
relief of cold and flu symptoms.


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.

Special warnings about this medicine
You can use this medicine while you are taking oral
contraceptives (“the pill”) or anticonvulsant tablets
used to treat epilepsy, but the medicine may not
work so well on your pain or fever.
I Night-time tablets may cause drowsiness.
If affected, do not drive or operate machinery. Avoid
alcoholic drink.

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1 What the medicine is for

If you have prostate problems (difficulty with
passing water or needing to pass water often).
I If you are taking alcohol.
I If you are taking any other medicines, including:
I anticholinergic drugs e.g.:
I tricyclic antidepressants (drugs used to treat
mood disorders).
I barbiturates (a kind of sleeping tablet).
I antidepressants (drugs used to treat mood
I sympathomimetic drugs (stimulants or appetite
suppressants and drugs used to treat congestion
and asthma).
I antihypertensives (drugs used to treat high blood
I colestyramine (used to lower blood cholesterol).
I metoclopramide or domperidone (used to treat
nausea and vomiting).
I anticoagulants (drugs used to thin the blood,
such as warfarin).
I anticonvulsants (drugs used to treat epilepsy).
I oral contraceptives ("the pill").
If you are not sure about any of the medicines you are
taking, show the bottle or pack to your pharmacist.
If any of these bullet points apply now or in the past,
talk to a doctor or pharmacist.

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


Barcodes placed at 14 mm
Hight for bars : 10 mm
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3 How to take this medicine

4 Possible side-effects

Check the table below to see how much
medicine to take.

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

For oral use only.
Do not take more than the stated dose shown below.
I Take with a glass of water.


Children under 12 years old

If you experience any of the following, stop
using the medicine and seek immediate help:

This medicine is not recommended for children
under 12 years old.


Adults and children aged 12 years
and over



Adults and children
aged 12 years
and over

1 white tablet every 4 - 6
hours, up to 3 times a day
(one tablet in the morning, at
mid-day and in the afternoon).
1 blue tablet to be taken at night.

Do not take more than 3 white tablets a day.
Take only 1 tablet at a time and only at the times of
day described in this table.
I Do not take the night-time tablets during the day.
I If symptoms persist, talk to your doctor.


If anyone has too much
Immediate medical advice should be sought in the
event of an overdose, even if you feel well, because
of the risk of delayed, serious liver damage.


If you forget to take the medicine
You should only take this medicine as required following
the dosage instructions above carefully.
If you forget to take a dose, take the next dose when
needed provided that the last dose was taken at least
4 hours ago. Do not take a double dose.

Allergic reactions including skin rashes (which may
be severe and include blistering or peeling of the
skin) and itching.

If you experience any of the following, stop
using the medicine and talk to your doctor:
A few people have had hallucinations but this is rare.
have been rare reports of blood disorders
although these were not necessarily related to
I A few men, especially men with prostate problems,
may have trouble passing water.

I There

Other effects which may occur include:
Having trouble getting to sleep.
Drowsiness, dizziness, blurred vision.
I Dry mouth, nose and throat.
I Upset stomach.

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.
Store in the original package.
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.

6 Further information
What’s in this medicine?
The active ingredients in Sudafed Decongestant &
Pain Tablets are: Day Tablets: 500 mg Paracetamol and 60
mg Pseudoephedrine hydrochloride.
Night Tablets: 500 mg Paracetamol and 25 mg
Diphenhydramine hydrochloride.
Other ingredients are:
Day Tablets: Pregelatinised maize starch, povidone,
crospovidone, stearic acid, microcrystalline cellulose,
croscarmellose sodium and magnesium stearate.
Night Tablets: Microcrystalline cellulose, maize starch,
sodium starch glycollate, pregelatinised maize starch,
hydroxypropylcellulose, croscarmellose sodium, stearic
acid, magnesium stearate and are coated with
methylcellulose (methocel E5), Opaspray M-1F-4315B
containing indigo carmine (E132), titanium dioxide
(E171) and propylene glycol.

What the medicine looks like
Sudafed Decongestant & Pain Tablets come in a carton
containing 12 white oblong day-time tablets and 4 blue
round night-time tablets.
Marketing Authorisation holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen Cilag S.A., Domaine de
Maigremont, 27100 Val de Reuil.
This leaflet was revised May 2010.
Sudafed is a registered trade mark.
09-1019 364867A

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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.