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BOOTS MUCUS COUGH RELIEF 100MG/5ML ORAL SOLUTION

Active substance(s): GUAIPHENESIN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Chesty Cough Relief 100 mg/5ml Oral Solution
Boots Mucus Cough Relief 100mg/5ml Oral Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Guaifenesin Ph Eur

3.

mg/5ml
100

PHARMACEUTICAL FORM
Oral solution

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
An expectorant for the relief of chesty coughs.

4.2

Posology and method of administration
Adults and children over 12 years:
Two 5ml spoonfuls every four hours up to four times a day.
Children under 12 years:
Not recommended.
Elderly:
There is no need for dosage reduction in the elderly.

4.3

Contraindications
Hypersensitivity to the active substance or any of the excipients.

4.4

Special warnings and precautions for use
Not recommended for children under 12 years.
Do not exceed the stated dose.
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.
Keep all medicines out of the reach of children.

4.5

Interaction with other medicinal products and other forms of interaction
There are no clinically significant interactions.
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 product during pregnancy and lactation has not been
established. However guaiphenesin 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 use of guaiphenesin 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 guaifenesin:
Gastrointestinal disorders: nausea, vomiting/gastrointestinal discomfort.
Immune system disorder: hypersensitivity reactions, including anaphylaxis.
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.

Pre-clinical Safety Data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid sugar
Hydroxyethylcellulose
Glycerin
Flav F menthol E43525
Potassium sorbate
Acesulfame K
Citric acid monohydrate
Sodium citrate
Food flavour 511630E TM
Blackcurrant 17407107
Purified water

6.2.

Incompatibilities
None stated.

6.3.

Shelf-Life
24 months.

6.4.

Special Precautions for Storage
Do not store above 25°C.
Do not refrigerate or freeze.

6.5.

Nature and Content of Container
An amber PET bottle with a polypropylene child resistant cap fitted with an
expanded polyethylene liner.
Pack size: 150ml, 240ml, 300ml

6.6

Special precautions for disposal
Not applicable.

7.

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

8.

MARKETING AUTHORISATION NUMBER(S)
PL 0014/0554

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/07/2010

10

DATE OF REVISION OF THE TEXT
29/09/2015

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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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