- Approval Id
- 8a7ca13bd690b388
- Drug Approval Emc Name
- Benylin Tickly Coughs Non-Drowsy
- Drug Name
- Benylin Tickly Coughs Non-Drowsy
- 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
- Legal Category
- General Sales List
- Authorisation Holder
- McNeil Products LimitedFoundation ParkRoxborough WayMaidenheadBerkshire SL6 3UGUnited Kingdom
- Authorisation Number
- PL 15513/0142
- Authorisation Date
- 11th January 2005
- Instruction Authorisation Holder
- McNeil Products LimitedFoundation ParkRoxborough WayMaidenheadBerkshire SL6 3UGUnited Kingdom
- Instruction Authorisation Number
- PL 15513/0142
- Instruction Authorisation Date
- 11th January 2005
- Instruction Composition
- | | |
| --- | --- |
| Active ingredient | per 5 ml |
| Glycerol | 0.75 ml |
| Sucrose | 1.707g |
For excipients see 6.1.
- Instruction Dosage Form
- Oral liquid
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of irritating, tickly dry coughs and sore throats.4.2 Posology and method of administration
For oral administration.Adults and children over 5 years: 10 mlChildren 1 5 years: 5 mlThe dose may be repeated three or four times a day.Children under one year: Not to be given to children under 1 year.Elderly: There is no need for dosage reduction in the elderly.4.3 Contraindications
Hypersensitivity or intolerance to any of the ingredients.4.4 Special warnings and precautions for use
Diabetics should take note of the carbohydrate content of this product.Do not give to children under one year.Keep all medicines out of the reach of children.Information relating specifically to excipients in the formulation.This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.4.7 Effects on ability to drive and use machines
Not applicable.4.8 Undesirable effects
No adverse effects would be anticipated.
\*\*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 would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors withing the respiratory tract.5.2 Pharmacokinetic properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.Sucrose is hydrolysed in the small intenstine by the enzyme sucrose to glucose and frucrose which are then absorbed.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Citric acid monohydrateSodium benzoate (E211)Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol,ethanol (alcohol)Black treacleLiquid glucosePurified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
No special precautions for storage.6.5 Nature and contents of container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.Alternative cap: A wadless polypropylene tamper evident cap.Pack size: 200ml.orAn amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.Pack size: 125ml and 150mlOrAn amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.Pack size: 150ml or 300ml.6.6 Special precautions for disposal and other handling
Not applicable.Administrative data
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Active ingredient | per 5 ml |
| Glycerol | 0.75 ml |
| Sucrose | 1.707g |
For excipients see 6.1.
## Pharmaceutical Form
Oral liquid
## Clinical Particulars
4.1 Therapeutic indications
For the relief of irritating, tickly dry coughs and sore throats.4.2 Posology and method of administration
For oral administration.Adults and children over 5 years: 10 mlChildren 1 5 years: 5 mlThe dose may be repeated three or four times a day.Children under one year: Not to be given to children under 1 year.Elderly: There is no need for dosage reduction in the elderly.4.3 Contraindications
Hypersensitivity or intolerance to any of the ingredients.4.4 Special warnings and precautions for use
Diabetics should take note of the carbohydrate content of this product.Do not give to children under one year.Keep all medicines out of the reach of children.Information relating specifically to excipients in the formulation.This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.4.7 Effects on ability to drive and use machines
Not applicable.4.8 Undesirable effects
No adverse effects would be anticipated.
\*\*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 would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors withing the respiratory tract.5.2 Pharmacokinetic properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.Sucrose is hydrolysed in the small intenstine by the enzyme sucrose to glucose and frucrose which are then absorbed.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
## Pharmaceutical Particulars
6.1 List of excipients
Citric acid monohydrateSodium benzoate (E211)Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol,ethanol (alcohol)Black treacleLiquid glucosePurified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
No special precautions for storage.6.5 Nature and contents of container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.Alternative cap: A wadless polypropylene tamper evident cap.Pack size: 200ml.orAn amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.Pack size: 125ml and 150mlOrAn amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.Pack size: 150ml or 300ml.6.6 Special precautions for disposal and other handling
Not applicable.Administrative data
