- Approval Id
- 0a90b4a0a5f93e04
- Drug Approval Emc Name
- Boots Chesty Cough Relief 100 mg/5ml Oral Solution
- Drug Name
- Boots Chesty Cough Relief 100 mg/5ml Oral Solution
- Company Address
- 1 Thane Road West, Beeston, Nottingham, NG2 3AA
- Company Telephone
- +44 (0)1159 595 165
- Atc Code
- R05CA03
- Legal Category
- General Sales List
- Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Authorisation Number
- PL 00014/0554
- Authorisation Date
- 21 April 1997
- Instruction Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Instruction Authorisation Number
- PL 00014/0554
- Instruction Authorisation Date
- 21 April 1997
- Instruction 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 |
- Instruction Dosage Form
- Oral solution
- Instruction 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 administration4.3 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."
- Instruction Pharmacology
- 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.
- Instruction 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 water6.2 Incompatibilities
None stated6.3 Shelf life
24 months6.4 Special precautions for storage
Do not store above 25ºC.
Do not refrigerate or freeze6.5 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, 300ml6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## 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 |
## Pharmaceutical Form
Oral solution
## 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 administration4.3 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."
## 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.
## 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 water6.2 Incompatibilities
None stated6.3 Shelf life
24 months6.4 Special precautions for storage
Do not store above 25ºC.
Do not refrigerate or freeze6.5 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, 300ml6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/the-boots-company-plc
