- Approval Id
- 363b8f62ee7e0e90
- Drug Approval Emc Name
- Boots Cough Syrup 3 Months Plus
- Drug Name
- Boots Cough Syrup 3 Months Plus
- Company Address
- 1 Thane Road West, Beeston, Nottingham, NG2 3AA
- Company Telephone
- +44 (0)1159 595 165
- Legal Category
- General Sales List
- Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
Trading as: BCM
- Authorisation Number
- PL 00014/0500
- Authorisation Date
- 11/01/2007
- Instruction Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
Trading as: BCM
- Instruction Authorisation Number
- PL 00014/0500
- Instruction Authorisation Date
- 11/01/2007
- Instruction Composition
- | | | |
| --- | --- | --- |
| \*\*Active ingredient\*\* | \*\*% v/v\*\* | \*\*ml/5ml\*\* |
| Glycerol Ph Eur | 15.0 | 0.75 |
- Instruction Dosage Form
- Syrup
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of dry tickly coughs.4.2 Posology and method of administration
For oral administration.
Children 3 months - 1 year: one 5ml spoonful three to four times a day.
Children 1 to 5 years: two 5ml spoonfuls three to four times a day.
Children under 3 months: not recommended.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
Not recommended for children under 3 months.
If symptoms persist for more than 3 days consult your doctor.
Keep all medicines out of the reach of children.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions.4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established but is not thought to constitute a hazard.4.7 Effects on ability to drive and use machines
No adverse effects known.4.8 Undesirable effects
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 with this product may possibly cause diarrhoea. Treatment should be symptomatic.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Glycerin has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.5.2 Pharmacokinetic properties
None stated.5.3 Preclinical safety data
Not applicable
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Maltitol liquid
Hydroxyethylcellulose
Sodium benzoate
Citric acid monohydrate
Sodium citrate
Apple flavouring 5112OIE
Purified water6.2 Incompatibilities
None stated6.3 Shelf life
36 months6.4 Special precautions for storage
Keep tightly closed.
Do not store above 25°C.6.5 Nature and contents of container
1) Bottle amber PET with polypropylene child resistant closure fitted with expanded polythene liner.
Pack size: 100ml and 150 ml
2) Bottle amber glass with polypropylene child resistant closure fitted with an expanded polyethylene liner.
Pack size 100, 125ml or 150ml.6.6 Special precautions for disposal and other handling
Not applicable
- Instruction Content
- ## Composition
| | | |
| --- | --- | --- |
| \*\*Active ingredient\*\* | \*\*% v/v\*\* | \*\*ml/5ml\*\* |
| Glycerol Ph Eur | 15.0 | 0.75 |
## Pharmaceutical Form
Syrup
## Clinical Particulars
4.1 Therapeutic indications
For the relief of dry tickly coughs.4.2 Posology and method of administration
For oral administration.
Children 3 months - 1 year: one 5ml spoonful three to four times a day.
Children 1 to 5 years: two 5ml spoonfuls three to four times a day.
Children under 3 months: not recommended.4.3 Contraindications
Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use
Not recommended for children under 3 months.
If symptoms persist for more than 3 days consult your doctor.
Keep all medicines out of the reach of children.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions.4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established but is not thought to constitute a hazard.4.7 Effects on ability to drive and use machines
No adverse effects known.4.8 Undesirable effects
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 with this product may possibly cause diarrhoea. Treatment should be symptomatic.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Glycerin has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.5.2 Pharmacokinetic properties
None stated.5.3 Preclinical safety data
Not applicable
## Pharmaceutical Particulars
6.1 List of excipients
Maltitol liquid
Hydroxyethylcellulose
Sodium benzoate
Citric acid monohydrate
Sodium citrate
Apple flavouring 5112OIE
Purified water6.2 Incompatibilities
None stated6.3 Shelf life
36 months6.4 Special precautions for storage
Keep tightly closed.
Do not store above 25°C.6.5 Nature and contents of container
1) Bottle amber PET with polypropylene child resistant closure fitted with expanded polythene liner.
Pack size: 100ml and 150 ml
2) Bottle amber glass with polypropylene child resistant closure fitted with an expanded polyethylene liner.
Pack size 100, 125ml or 150ml.6.6 Special precautions for disposal and other handling
Not applicable
- Company Detail Path
- /organization/the-boots-company-plc
