EXPECTORANT AND DECONGESTANT COUGH SYRUP

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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Expectorant and Decongestant Cough Syrup
Guaifenesin, Pseudoephedrine
Patient Information Leaflet
Read all of this leaflet carefully before you
take this medicine because it contains
important information you need to know.
This medicine is available without prescription,
however, you still need to use this product
carefully to get the best results from it. Keep this
leaflet as you may need to read it again. Ask your
pharmacist if you need more information or advice.
Treating cough and cold in children
It’s normal for children to get 8 or more colds in a
year. Gradually they build up immunity and get
fewer colds. Most colds will get better within a
few days and you may not need to do more than
keep your child comfortable until they get over it.
Because colds are caused by viruses, not
bacteria, antibiotics don’t help.
Here are simple steps to help your child who has
a cough or cold.
i. If they are hot/feverish: Increase the amount
of fluid your child normally drinks. Lower their
temperature with a paracetamol or ibuprofen
medicine which has doses for children.
(Paracetamol is not for children under 2 months.
Ibuprofen is not for children under 3 months)
ii. For coughs: Although it is distressing to hear
your child cough, in fact coughing serves a
purpose. It helps to clear phlegm on the chest or
mucus from the nose. Give the child plenty of
warm clear fluids to drink.
iii. To help with breathing: Plain saline nose
drops, available from your pharmacy, can help
babies with blocked noses who are having
trouble feeding.

1. What is this medicine and
what is it used for?
This medicine contains:
• guaifenesin which is an expectorant to help
loosen phlegm
• pseudoephedrine which is a decongestant to
reduce swelling in the passages of the nose to
help you breathe more easily.
This cough syrup is used to loosen stubborn
mucus (phlegm) and provide relief from chesty
coughs. It also relieves the symptoms of blocked
nose (nasal congestion), runny nose (catarrh) and
blocked sinuses (sinusitis).

2. Is this medicine suitable
for you?
Do not take this medicine if you:
• are allergic to guaifenesin, pseudoephedrine
or any of the other ingredients
• are in early pregnancy, unless your doctor has
told you to
• are taking, or have taken antidepressant drugs
called monoamine oxidase inhibitors (MAOI’s)
or reverse inhibitors of monoamine oxidase
(RIMA’s) within the last 2 weeks (e.g.
phenelzine, isocarboxazid, moclobemide)
• are taking other decongestant or cough and
cold medicines
• are taking beta blockers (used to treat high
blood pressure)
• have porphyria, which is a type of blood disorder
that causes skin or nervous system problems
• have an addiction to alcohol
• have heart disease
• have severe kidney problems
• have high blood pressure (hypertension)
• have diabetes
• have closed angle glaucoma (increased
pressure in the eye)
• have an overactive thyroid
• have a tumour of the adrenal gland
(phaeochromocytoma).
Do not give to your child if they are under 6 years.
Please see your doctor or pharmacist before
taking this medicine if you:
• are pregnant or breastfeeding
• suffer from a very bad cough or if your cough
lasts for more than 5 days, or comes back,
or if you also have a fever, rash or persistent
headache
• suffer from an irregular heart rate (arrhythmias)
• suffer from liver problems, including alcoholic
liver disease
• suffer from epilepsy
• suffer from blood circulation disorders
• have a long-term cough or asthma, or are
having an asthma attack
• have an enlarged prostate gland
• have kidney problems
• have an intolerance to some sugars.
Please turn over ➥

2. Is this medicine suitable
for you? (Continued)
If you are taking any of the following
medicines please see your doctor:
• medicines to treat high blood pressure, including
alpha and beta blockers
• oxytocin, used in pregnant women to start labour
• cough suppressants (e.g. dextromethorphan,
pholcodine)
• cardiac glycosides, which are medicines for
heart problems (e.g. digoxin)
• ergot alkaloids for the treatment of migraine
(e.g. ergotamine, methysergide)
• appetite suppressants (e.g. orlistat, sibutramine)
and stimulants (e.g. dexamfetamine)
• antimuscarinic/anticholinergic drugs, such as
tricyclic antidepressants (e.g. amitriptyline), or
atropine (used to treat some heart, eye and
bowel conditions).
Information about some of the ingredients in
this medicine:
Contains alcohol (ethanol).
This medicinal product contains 2.85% volume of
ethanol (alcohol) i.e. up to 351 mg per 15 ml dose,
equivalent to 8.5 ml of beer, 3.6 ml wine per dose.
Harmful for those suffering from alcoholism. To be
taken into account in pregnant or breastfeeding
women, children and high risk groups such as
patients with liver disease, or epilepsy.
Contains sorbitol (E420).
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
Contains the colouring agent ponceau 4R
(E124). May cause allergic reactions.

3. How to take this medicine
Shake the bottle well before use. Measure the
syrup using the dosing cup provided.
Adults, the elderly and children over 12
years: 15 ml.
Children 6 – 12 years: 7.5 ml. If the child’s
symptoms get worse while taking this syrup see
your doctor. Not to be used for more than 5 days
without the advice of a doctor.
Each dose should be taken as required, but do not
repeat the dose more frequently than every 6 hours.
Not more than 3 doses should be taken in any
24 hours.
Do not exceed the stated dose.
Do not give to children under 6 years of age.

Do not take with any other cough and cold
medicine.
If your symptoms persist or worsen, you must
see a doctor or pharmacist.
If you take too much cough liquid by mistake,
contact your doctor or pharmacist straight away.
Very large doses can cause sickness (nausea and
vomiting).

4. Possible side effects
Most people do not have any side effects while
taking this medicine. However, if you experience
any side effects, or anything else unusual happens,
stop taking the medicine immediately, and see
your doctor or pharmacist.
Side effects which may occur are:
• an irregular heart beat, high blood pressure
• anxiety, excitability
• headache
• restlessness, irritability
• difficulty sleeping (insomnia).
• stomach ache and discomfort, nausea (feeling
sick), vomiting (being sick)
• hallucinations, feelings of paranoia
• allergic reactions such as skin rash
• difficulty passing urine.

5. How to store your medicine
Keep all medicines out of the reach and
sight of children.
Do not store above 25°C.
Do not use this medicine after the expiry date
printed on the pack.

6. What is in this medicine?
Each 15 ml dose of liquid contains the active
ingredients: guaifenesin 200 mg and
pseudoephedrine hydrochloride 60 mg.
The other ingredients are: water, alcohol, glycerin,
menthol, sorbitol (E420), sodium cyclamate,
sodium saccharin, carrageenan gum, potassium
sorbate, flavourings and the colours ponceau 4R
(E124) and caramel (E150).
This product is available in a pack size of 150 ml.

7. Who makes this medicine?
The Marketing Authorisation holder and
manufacturer is Wrafton Laboratories Limited,
Braunton, Devon, EX33 2DL, UK.
Text Revised: June 2010.
PL 12063/0022

2731793

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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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