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BOOTS CHESTY COUGH SYRUP 6 YEARS +

Active substance(s): GUAIPHENESIN / GUAIPHENESIN / GUAIPHENESIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Chesty Cough Syrup 6 Years +

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Guaifenesin Ph Eur

3

Per 5m1
50mg

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Expectorant for the symptomatic relief of acute productive (chesty) cough.

4.2

Posology and method of administration
Children 6 to 12 years: 10ml-20ml
The dose may be given every 4 hours up to four times a day. Not more than 4
doses should be given in any 24 hours.
Do not exceed the stated dose.
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 or carers should seek medical attention if the
child's condition deteriorates during treatment.
For oral administration.
Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

4.3

Contraindications
Hypersensitivity to the active substance or any of the excipients.
Not to be used in children under the age of 6 years.

4.4

Special warnings and precautions for use
Ask a doctor before use if you suffer from a chronic cough, if you have asthma
or are suffering from an acute asthma attack.
Stop use and ask a healthcare professional if your cough lasts for more than 5
days, comes back, or is accompanied by a fever, rash, or persistent headache.
Do not take with a cough suppressant.
Do not give this medicine with any other cough or cold medicines.

4.5

Interaction with other medicinal products and other forms of interaction
There are no clinically significant drug interactions.
Other forms of interaction: If urine is collected within 24 hours of a dose of
guaifenesin a metabolite of guaifenesin may cause a colour interference with
laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA)
and vanillylmandelic acid (VMA).

4.6

Pregnancy and lactation
The safety of this medicine during pregnancy and lactation has not been
established. However, guaifenesin is not considered to constitute a hazard
during pregnancy since there is no evidence of an association with foetal
malformations. There is no data available on the use of guaifenesin during
breast feeding.

4.7

Effects on ability to drive and use machines
No adverse effects known.

4.8

Undesirable effects
The following side effects may be associated with the use of gauifenesin:
Gastrointestinal Disorders: Nausea, vomiting, gastrointestinal discomfort.
Immune System Disorders: Hypersensitivity reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to report
any suspected adverse reactions via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Overdosage may give rise to nausea and vomiting. Treatment need only be
symptomatic and supportive.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Guaifenesin reduces the viscosity of tenacious sputum and is used as an
expectorant.

5.2

Pharmacokinetic properties
Guaifenesin is readily absorbed from the gastrointestinal tract. It is metabolised and
excreted in the urine.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maltitol liquid
Glycerin
Natrosol 250 HX
Citric acid monohydrate gran
Sodium saccharin cryst (76% Saccharin)
Sodium citrate gran
Sorbic acid
Flav F blackberry 50l0l6A
Food flavour 511630E Tastemaker
Levomenthol
Purified water
Alcohol 96%

6.2

Incompatibilities
None stated.

6.3

Shelf-life
24 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
An amber coloured polyethylene terephthalate bottle with a polypropylene
child resistant closure fitted with an expanded polyethylene liner.
Pack size: l50ml, l00ml

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0381

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/04/2005

10

DATE OF REVISION OF THE TEXT
14/07/2015

Expand Transcript

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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