Boots Pharmaceuticals Chesty Cough & Congestion Relief Oral Solution Guaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE; Guaiphenesin

Available from:

The Boots Company Plc

ATC code:

R01BA; R01BA52

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE; Guaiphenesin

Dosage:

100/30 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics; pseudoephedrine, combinations

Authorization status:

Marketed

Authorization date:

2000-05-12

Patient Information leaflet

INFORMATION FOR THE USER
Chesty Cough & Congestion Relief Oral Solution
(Guaifenesin 100 mg/5 ml, Pseudoephedrine Hydrochloride 30
mg/5 ml)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat minor
conditions. However, you still
need to take it 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
WHAT THIS MEDICINE IS FOR
This medicine contains Pseudoephedrine, a decongestant, which acts to
relieve a blocked
nose. It also contains Guaifenesin, an expectorant, which acts to
loosen and relieve phlegm
on the chest.
It can be used to relieve the symptoms of a chesty cough, catarrh and
a blocked nose
without causing drowsiness.
For children, simple treatments should be tried first before you give
this medicine. Further
information on “TREATING COUGHS AND COLDS IN CHILDREN” is provided
at the end of this
leaflet.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children of 6 years and over.
However, some
people should not take this medicine or should seek the advice of
their pharmacist or doctor
first.
X DO NOT TAKE:

IF YOU ARE ALLERGIC to any of the ingredients in this medicine (see
“What is in this medicine”)

IF YOU ARE ALLERGIC TO OTHER DECONGESTANTS

IF YOU HAVE SEVERE KIDNEY PROBLEMS

IF YOU HAVE HEART OR BLOOD VESSEL DISEASE

IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near
your kidney)

IF YOU HAVE DIABETES

IF YOU HAVE AN OVERACTIVE THYROID

IF YOU HAVE RAISED PRESSURE IN THE EYE (glaucoma)

IF YOU HAVE DIFFICULTY IN PASSING URINE

IF YOU ARE TAKING ANY OF THESE MEDICINES:
- Monoamine oxidase inhibitors or moclobemide (for depression), or have
taken them in the
last 14 days
- Medicines which may cause a dry mouth (e.g. tricyclic
antidepressants)
- Medicines to reduce your appetite or stimulant medicines
- Medicines called beta-blockers (

Summary of Product characteristics

Health Products Regulatory Authority
14 October 2020
CRN009V6X
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Chesty Cough & Congestion Relief Oral Solution
Guaifenesin 100 mg/5 mlPseudoephedrine
Hydrochloride 30 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains
Guaifenesin
100 mg
Pseudoephedrine hydrochloride
30 mg
Excipients: contains 1.77g sucrose and 0.3mg carmoisine per 5ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, bright purple syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
An expectorant for the relief of chesty coughs, nasal congestion and
catarrh without causing drowsiness.
For children aged 6 to12 years: An expectorant for the relief of
chesty coughs, nasal congestion and catarrh (without causing
drowsiness) when simple measures have failed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
Adults and children 12 years and over: 10ml four times a day.
Elderly: There is no need for dosage reduction in the elderly.
Children 6-12 years: 5ml three times a day.
This medicine is contraindicated in children under 6 years of age (see
section 4.3).
Children of 6-12 years of age: not to be used for more than 5 days
without the advice of a doctor. Parents and carers should
seek medical attention if the child's condition deteriorates during
treatment.
Warning: Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients.
Severe renal impairment.
Cardiovascular disease including hypertension and ischaemic heart
disease
Diabetes mellitus.
Phaeochromocytoma.
Health Products Regulatory Authority
14 October 2020
CRN009V6X
Page 2 of 5
Hyperthyroidism.
Closed angle glaucoma.
Prostatic enlargement (patients with prostatic hypertrophy may have
increased difficulty in micturition).
Urinary retention
Use in patients who are currently receiving other sympathomimetic
drugs (such