Boots Mucus Cough Relief 100mg/5ml Oral Solution

Summary of Product Characteristics Updated 23-May-2025 | THE BOOTS COMPANY PLC

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

100 mg/5ml

Excipients with known effect

glycerin

liquid sugar (sucrose)

1 ml/ 5 ml

2 ml/ 5 ml

3. 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.

For oral administration

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

Not recommended for children under 12 years.

4.4 Special warnings and precautions for use

Should not be used with other cough and cold medicines.

Patients should consult a doctor if they are suffering from a chronic cough such as the one that occurs with smoking, asthma, chronic bronchitis or emphysema. Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.

Do not exceed the stated dose.

Keep all medicines out of the reach of children.

This medicine contains glycerin. May cause headache, stomach upset and diarrhoea.

This medicine contains liquid sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.

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 Fertility, pregnancy and lactation

If pregnant or breastfeeding, consult a healthcare professional before use.

The safety of guaifenesin when used during pregnancy has not been established. Medical advice should be sought before using guaifenesin during pregnancy and it should not be used unless the potential benefit to the mother clearly outweighs the possible risk to the developing foetus.

Breastfeeding

Guaifenesin is excreted in breast milk in small quantities.

Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Adverse reactions identified during post-marketing use are listed below by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown.

Immune system disorders :

Hypersensitivity reactions, anaphylactic reactions, angioedema

Respiratory, Thoracic and Mediastinal Disorders

Dyspnoea*

*dyspnoea has been reported in association with other symptoms of hypersensitivity

Gastrointestinal disorders:

Nausea, vomiting/gastrointestinal discomfort.

Skin and Subcutaneous Tissue Disorders

Urticaria, rash

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 or search for MHRA Yellow Card in the Google Play or Apple App store.

4.9 Overdose

In case of overdose, discontinue use and seek professional assistance immediately.

Overdosage may give rise to nausea and vomiting.

Appropriate supportive therapy dependent upon individual response to the preparation. Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated. Further management should be as clinically indicated or as recommended by the national poison centres where available."

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Expectorant ATC code: RO5CAO3

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

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 contents 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 and other handling

Not applicable.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0554

9. Date of first authorisation/renewal of the authorisation

21 April 1997

10. Date of revision of the text

16/05/2025

Company Contact Details
THE BOOTS COMPANY PLC
Address

1 Thane Road West, Beeston, Nottingham, NG2 3AA

Fax

+44 (0)1159 592 565

Telephone

+44 (0)1159 595 165