- Approval Id
- a9298caa0388900d
- Drug Approval Emc Name
- Benylin Infant's Cough Syrup
- Drug Name
- Benylin Infant's Cough Syrup
- Company Name
- McNeil Products Ltd
- Company Address
- 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, UK
- Company Medical Info Direct Line
- 0808 238 9999 (freephone)
- Company Medical Info Email
- consumer-gb@kenvue.com
- Atc Code
- R05FB01
- Legal Category
- General Sales List
- Authorisation Holder
- McNeil Products Limited
50 - 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
- Authorisation Number
- PL 15513/0168
- Authorisation Date
- 19 March 2009
- Instruction Authorisation Holder
- McNeil Products Limited
50 - 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
- Instruction Authorisation Number
- PL 15513/0168
- Instruction Authorisation Date
- 19 March 2009
- Instruction Composition
- | | | |
| --- | --- | --- |
| \*\*Active ingredient\*\* | \*\*% v/v\*\* | \*\*Quantity per 5 ml\*\* |
| Glycerol | 15.0 | 0.75ml |
\*\*Excipient with known effect\*\*:
| | | |
| --- | --- | --- |
| Maltitol liquid (E965) | | 1.5ml |
| Sodium | | 6.95mg |
| Sodium benzoate (E211) | | 10mg |
| Propylene glycol (E1520) | | 18.24mg |
For the full list of excipients, see section 6.1
- Instruction Dosage Form
- Syrup
A clear colourless syrup with an apple flavour.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of dry tickly coughs.4.2 Posology and method of administration
\*\*Posology\*\*
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.
\*\*Method of administration\*\*
For oral use.4.3 Contraindications
Hypersensitivity to the active substance or to any of the ingredients listed in section 6.1.
Not recommended for children under 3 months.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use
Diabetics should take note that glycerol may affect blood sugar levels.
If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor.
This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
This medicine contains 10 mg sodium benzoate (E211) in each 5ml which is equivalent to 2mg/ml.
This medicine contains 18.24 mg propylene glycol (E1520) in each 5ml which is equivalent to 3.65 mg/ml.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions.4.6 Fertility, pregnancy and lactation
Not applicable.4.7 Effects on ability to drive and use machines
This medicine has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
Maltitol may have a mild laxative effect.
\*\*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
\*\*Symptoms\*\*
Overdose with this product may possibly cause diarrhoea.
\*\*Treatment\*\*
Treatment should be symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01.
Glycerol has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.5.2 Pharmacokinetic properties
\*\*Absorption\*\*
Glycerol is readily absorbed from the gastrointestinal tract.
\*\*Distribution\*\*
Glycerol combines with free fatty acids in the liver to form triglycerides which are distributed to the adipose tissues.
\*\*Metabolism\*\*
Glycerol undergoes extensive metabolism principally in the liver and to a lesser extent in the kidneys. Glycerol is metabolised to glucose or glycogen or oxidized to carbon dioxide and water.
\*\*Elimination\*\*
Glycerol may be excreted in the urine unchanged.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Maltitol liquid (E965)
Hydroxyethylcellulose
Sodium benzoate
Citric acid monohydrate
Sodium citrate
Apple flavouring 5112OIE (containing propylene glycol)
Purified water6.2 Incompatibilities
None stated6.3 Shelf life
3 years6.4 Special precautions for storage
Keep the bottle 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.
A spoon with a 5 ml, 2.5 ml and 1.25 ml measure is supplied with this pack.
Pack size: 100 ml and 150 ml.
Contained in a box board carton.
2) Bottle amber glass with polypropylene child resistant closure fitted with an expanded polyethylene liner.
A spoon with a 5 ml, 2.5 ml and 1.25 ml measure is supplied with this pack.
Pack size 100, 125ml or 150ml.
Contained in a box board carton.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
| | | |
| --- | --- | --- |
| \*\*Active ingredient\*\* | \*\*% v/v\*\* | \*\*Quantity per 5 ml\*\* |
| Glycerol | 15.0 | 0.75ml |
\*\*Excipient with known effect\*\*:
| | | |
| --- | --- | --- |
| Maltitol liquid (E965) | | 1.5ml |
| Sodium | | 6.95mg |
| Sodium benzoate (E211) | | 10mg |
| Propylene glycol (E1520) | | 18.24mg |
For the full list of excipients, see section 6.1
## Pharmaceutical Form
Syrup
A clear colourless syrup with an apple flavour.
## Clinical Particulars
4.1 Therapeutic indications
For the relief of dry tickly coughs.4.2 Posology and method of administration
\*\*Posology\*\*
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.
\*\*Method of administration\*\*
For oral use.4.3 Contraindications
Hypersensitivity to the active substance or to any of the ingredients listed in section 6.1.
Not recommended for children under 3 months.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use
Diabetics should take note that glycerol may affect blood sugar levels.
If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor.
This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
This medicine contains 10 mg sodium benzoate (E211) in each 5ml which is equivalent to 2mg/ml.
This medicine contains 18.24 mg propylene glycol (E1520) in each 5ml which is equivalent to 3.65 mg/ml.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions.4.6 Fertility, pregnancy and lactation
Not applicable.4.7 Effects on ability to drive and use machines
This medicine has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
Maltitol may have a mild laxative effect.
\*\*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
\*\*Symptoms\*\*
Overdose with this product may possibly cause diarrhoea.
\*\*Treatment\*\*
Treatment should be symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01.
Glycerol has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.5.2 Pharmacokinetic properties
\*\*Absorption\*\*
Glycerol is readily absorbed from the gastrointestinal tract.
\*\*Distribution\*\*
Glycerol combines with free fatty acids in the liver to form triglycerides which are distributed to the adipose tissues.
\*\*Metabolism\*\*
Glycerol undergoes extensive metabolism principally in the liver and to a lesser extent in the kidneys. Glycerol is metabolised to glucose or glycogen or oxidized to carbon dioxide and water.
\*\*Elimination\*\*
Glycerol may be excreted in the urine unchanged.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
## Pharmaceutical Particulars
6.1 List of excipients
Maltitol liquid (E965)
Hydroxyethylcellulose
Sodium benzoate
Citric acid monohydrate
Sodium citrate
Apple flavouring 5112OIE (containing propylene glycol)
Purified water6.2 Incompatibilities
None stated6.3 Shelf life
3 years6.4 Special precautions for storage
Keep the bottle 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.
A spoon with a 5 ml, 2.5 ml and 1.25 ml measure is supplied with this pack.
Pack size: 100 ml and 150 ml.
Contained in a box board carton.
2) Bottle amber glass with polypropylene child resistant closure fitted with an expanded polyethylene liner.
A spoon with a 5 ml, 2.5 ml and 1.25 ml measure is supplied with this pack.
Pack size 100, 125ml or 150ml.
Contained in a box board carton.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
