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ROBITUSSIN CHESTY COUGH WITH CONGESTION

Active substance(s): GUAIPHENESIN / PSEUDOEPHEDRINE HYDROCHLORIDE

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PAA059041

MUCUS COUGH

AND CONGESTION RELIEF

Guaifenesin and
Pseudoephedrine

20mg, 6mg/ml Oral Solution

Read all of this leaflet carefully because it contains important information for you
This medicine is available without prescription. However, you still need to use this medicine carefully
to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 7 days.
- If any of the side effects get serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Robitussin Mucus Cough and Congestion Relief is and what it is used for
2. Before you take Robitussin Mucus Cough and Congestion Relief
3. How to take Robitussin Mucus Cough and Congestion Relief
4. Possible side effects
5. How to store Robitussin Mucus Cough and Congestion Relief
6. Further information
1. What Robitussin Mucus Cough and Congestion Relief is and what it is used for
This medicine contains the active ingredients guaifenesin and pseudoephedrine hydrochloride.
Guaifenesin belongs to a group of medicines called cough expectorants and works by changing an
unproductive cough to a cough that is more productive and less frequent. Pseudoephedrine
hydrochloride belongs to a group of medicines called nasal decongestants and works by providing
symptomatic relief of the common cold.
2. Before you take Robitussin Mucus Cough and Congestion Relief
Do not take this medicine if:
- You are allergic (hypersensitive) to guaifenesin or pseudoephedrine hydrochloride or any of the
other ingredients in this medicine.
- You are suffering from heart disease, an overactive thyroid gland, increased pressure in your eyes
(glaucoma), diabetes, an enlarged prostate gland or have difficulty passing urine.
- You are taking a monoamine oxidase inhibitor (MAOI) medicine for depressive illness, such as
Moclobemide, or have done so in the last 14 days.
Take special care and talk to your doctor or pharmacist before taking this medicine if you have had a
cough for a long time, or if you have asthma or are suffering from an asthma attack.
Taking other medicines:
Talk to your doctor or pharmacist before taking this medicine if:
- You are taking digoxin, used to treat some heart conditions.
- You are taking medicines to reduce blood pressure.
- You are taking another decongestant product (e.g. sympathomimetics such as phenylephrine).
- You are taking a medicine to control the symptoms of asthma (e.g. an inhaled beta-agonist such
as Salbutamol).
- You are taking a medicine for depression (e.g. a tricyclic anti-depressant such as amitriptyline).
Pregnancy and breastfeeding
Talk to your doctor before taking this medicine if you are pregnant or breastfeeding.
Important information about some of the ingredients in this medicine:
- This product contains amaranth (E123), which may cause allergic reactions.
- If you have been told that you have an intolerance to some sugars, contact your doctor before
taking this medicine as it contains sorbitol and maltitol.
- This medicine contains 25.2 mg of sodium per 10 ml dose. This should be taken into account by
those who are on a controlled sodium diet.
- This medicinal product contains 2.7 % v/v alcohol (ethanol) (214 mg per 10 ml dose). This is
equivalent to approximately 2 ml wine per dose which can be harmful for those suffering from
alcoholism and should be taken into account if you are pregnant or breastfeeding or have liver
disease or epilepsy. This will have no or negligible influence on your ability to drive.
3. How to take Robitussin Mucus Cough and Congestion Relief
For oral use only.
Adults, the elderly and children over 12 years: Take 10 ml up to four times daily, as required.
Children under 12 years: Do not use.
Use the dosing cup provided with the pack.
Do not exceed the stated dose. No more than four doses should be taken in any 24 hours.
Stop using this medicine and ask a healthcare professional if you have had a cough for more than
7 days or if you have any other symptoms which might be related to your cough, for example fever,
rash, persistent headache or shortness of breath.
If you take more medicine than you should:
If you take too much of this medicine, consult your doctor or hospital immediately.
Bring any remaining medicine with you to show the doctor.

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If you forget to take your medicine:
Take a dose when you need to, provided the last dose was taken at least 4 hours ago. Do not take a
If you forget
take
double
dose to to
make
up your
for themedicine:
one you have missed.
Take a dose when you need to, provided the last dose was taken at least 4 hours ago. Do not take a
4. Possible side effects
double dose to make up for the one you have missed.
Like all medicines, your medicine can cause side effects, although not everybody gets them. Side
4. Possible
side effects
effects
with guaifenesin
or pseudoephedrine are rare. However, susceptible individuals may
Like all medicines,
your
medicine
experience
unwanted
side
effects.can cause side effects, although not everybody gets them. Side
effects with guaifenesin or pseudoephedrine are rare. However, susceptible individuals may
If you experience any of the following serious effects then STOP taking this medicine immediately
experience unwanted side effects.
and contact your doctor or pharmacist:
experience
any ofSymptoms
the following
serious
effects
taking
this medicine
immediately
-If you
Allergic
reactions.
could
include
itchy then
skin STOP
or rashes,
difficulty
breathing,
faster heart
and rate,
contact
your doctor
or pharmacist:
swelling
of the face
or throat.
Allergic
include
itchy skin or rashes, difficulty breathing, faster heart
- A
feelingreactions.
your heartSymptoms
is beatingcould
too fast
or palpitations.
rate, swelling of the face or throat.
Other possible side effects
- A feeling your heart is beating too fast or palpitations.
If any of the side effects below get serious or you experience any other side effects, stop taking this
Other possible
sideand
effects
medicine
immediately
consult your doctor:
of the sick
side (nausea)
effects below
get sick
serious
or you experience any other side effects, stop taking this
-If any
Feeling
or being
(vomiting).
immediately
andfeeling
consultrestless
your doctor:
-medicine
Dizziness,
headache,
or overactive.
sick (nausea)
or being
sick (vomiting).
- Feeling anxious,
irritable
or nervous.
Dizziness,
headache,
or overactive.
- If
you cannot
sleep, orfeeling
suffer restless
from hallucinations.
Feeling
anxious,
irritable or nervous.
- Skin
rashes
or hives.
- If
cannot sleep,
or suffer from hallucinations.
Anyou
increased
blood pressure.
Skin rashes
or hives.
- Difficulty
passing
urine.
- An increased blood pressure.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
- Difficulty passing urine.
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
If you
get any side effects, talk to your doctor,
pharmacist
or nurse.
any possible
at:
www.mhra.gov.uk/yellowcard.
By reporting
side effects
youThis
canincludes
help provide
more side
effects not listed
this leaflet.
can also report side effects directly via the Yellow Card Scheme
information
on theinsafety
of thisYou
medicine.
at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
5. How to store Robitussin Mucus Cough and Congestion Relief
information on the safety of this medicine.
- Do not use this medicine after the expiry date shown on the top end of the carton.
5.
to store
storeabove
Robitussin
- How
Do not
25°C. Mucus Cough and Congestion Relief
Do notout
use
expiry date shown on the top end of the carton.
- Keep
of this
the medicine
sight and after
reachthe
of children.
- Do not store above 25°C.
6. Further information
- Keep out of the sight and reach of children.
What Robitussin Mucus Cough and Congestion Relief contains:
6. Further
information
Each
5 ml contains
100 mg of the active substance guaifenesin and 30 mg of the active substance
What Robitussinhydrochloride.
Mucus Cough and Congestion Relief contains:
pseudoephedrine
Each 5 ml contains 100 mg of the active substance guaifenesin and 30 mg of the active substance
Robitussin Mucus Cough and Congestion Relief also contains: Glycerol, Carmellose
pseudoephedrine hydrochloride.
Sodium, Disodium Edetate, Sodium Benzoate (E211), Sodium Cyclamate, Amaranth (E123), Ethanol
Robitussin
Mucus Maltitol
Cough (E965),
and Congestion
Relief
also
contains:
Glycerol,
Carmellose
(96%), Levomenthol,
Sorbitol Solution
70%,
Natural
Cherry
Flavouring,
Citric Acid
Sodium, Disodium
Edetate,
Benzoate
(E211),and
Sodium
Cyclamate,
Anhydrous,
Caramel
(E150),Sodium
Acesulfame
Potassium
Purified
Water. Amaranth (E123), Ethanol
(96%), Levomenthol, Maltitol (E965), Sorbitol Solution 70%, Natural Cherry Flavouring, Citric Acid
Robitussin Mucus Cough and Congestion Relief is a liquid, supplied in a 100 ml botle.
Anhydrous, Caramel (E150), Acesulfame Potassium and Purified Water.
Who makes and supplies this medicine:
Robitussin Mucus Cough and Congestion Relief is a liquid, supplied in a 100 ml botle.
The Marketing Authorisation holder for Robitussin Mucus Cough and Congestion Relief is:
Who makes
andHealthcare
suppliesLtd,
thisRamsgate
medicine:
Pfizer
Consumer
Road, Sandwich, Kent, CT13 9NJ, UK.
The Marketing Authorisation holder for Robitussin Mucus Cough and Congestion Relief is:
The dosing cup is manufactured by:
Pfizer Consumer Healthcare Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3N2, Canada.
The dosing cup is manufactured by:
The EU Authorised Representative is: Pfizer Consumer Healthcare Ltd.
Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3N2, Canada.
This medicine is manufactured by:
The EU Authorised Representative is: Pfizer Consumer Healthcare Ltd.
Wyeth Pharmaceuticals, New Lane, Havant, Hampshire, PO9 2NG, United Kingdom.
This medicine is manufactured by:
OR:
Pharmaceuticals,
New Lane, 90,
Havant,
Hampshire,
Wyeth Lederle
S.r.l., Via Nettunese
04011
Aprilia (LT)PO9
Italy.2NG, United Kingdom.
OR:
If you have any queries, comments about this medicine or require information in large print, tape or
Wyeth Lederle S.r.l., Via Nettunese 90, 04011 Aprilia (LT) Italy.
CD please contact the Careline by phone or write to:
If
you havePfizer
any queries,
comments
about
Careline,
Consumer
Healthcare
Ltd,this medicine or require information in large print, tape or
CD
please
contact
theKT20
Careline
phone or write to:
Walton
Oaks,
Surrey,
7NS,byUK.
Careline,
Pfizer Consumer Healthcare Ltd,
or carelineUK@pfizer.com
Walton Oaks, Surrey, KT20 7NS, UK.
or
carelineUK@pfizer.com
Leaflet
prepared: April 2014
PL 00165/0098
prepared: April 2015
2014
Leaflet
MA111/00401
PL 00165/0098
MA111/00401
PAA046705
PAA046705
PAA059041

PAA059041.indd 2

2015/04/08 10:06 AM

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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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