Skip to content
SPC Logo

Benylin Tickly Coughs & Sore Throat Non-Drowsy Syrup

Last Updated on eMC 03-Feb-2017 View changes  | McNeil Products Ltd Contact details

1. Name of the medicinal product

Benylin Tickly Coughs & Sore Throat Non-Drowsy Syrup

2. Qualitative and quantitative composition

Active ingredient

per 5 ml

Glycerol

0.75 ml

Sucrose

1.707g

Excipients with known effect:

Liquid Glucose

2.342g

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Syrup

4. Clinical particulars
4.1 Therapeutic indications

For the relief of irritating, tickling dry coughs and sore throats.

4.2 Posology and method of administration

Posology:

Adults and children over 5 years: 10 ml

Children 1 – 5 years: 5 ml

The 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.

Method of administration:

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

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 sight and 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 Fertility, 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 relevant.

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

Management:

Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01

Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within 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 intestine by the enzyme sucrase to glucose and fructose 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.

6. Pharmaceutical particulars
6.1 List of excipients

Citric acid monohydrate

Sodium benzoate (E211)

Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol, ethanol (alcohol)

Black treacle

Liquid glucose

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

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: 200 ml

Or

An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.

Pack size: 125ml or 150ml

Or

An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.

Alternative cap: An aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.

Pack size: 150ml or 300ml

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.

7. Marketing authorisation holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing authorisation number(s)

PL 15513/0142

9. Date of first authorisation/renewal of the authorisation

11th January 2005

10. Date of revision of the text

25-Jan-17

Company contact details

McNeil Products Ltd

Company image
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail
Medical Information Direct Line

01344 864042

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

glycerol, sucrose

Legal categories

GSL - General Sales List

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue