Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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?

Summary of Product Characteristics last updated on the eMC: 09/08/2007
SPC Benylin Children's Tickly Coughs


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Infant Simple Cough Linctus 3 Months Plus or Infant Sugar Free Simple Cough Linctus or Children's 3 Months Plus Simple Cough Linctus or Boots Cough Syrup 3 Months Plus or Benylin Children's Tickly Coughs or CalCough Tickly


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

% v/v

ml/5ml

Glycerol Ph Eur

15.0

0.75


Go to top of the page
3. PHARMACEUTICAL FORM

Syrup


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

For the relief of dry tickly coughs.


Go to top of the page
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.


Go to top of the page
4.3 Contraindications

Hypersensitivity to any of the ingredients.


Go to top of the page
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.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions.


Go to top of the page
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.


Go to top of the page
4.7 Effects on ability to drive and use machines

No adverse effects known.


Go to top of the page
4.8 Undesirable effects

No adverse effects known.


Go to top of the page
4.9 Overdose

Overdosage with this product may possibly cause diarrhoea. Treatment should be symptomatic.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Glycerin has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.


Go to top of the page
5.2 Pharmacokinetic properties

None stated.


Go to top of the page
5.3 Preclinical safety data

Not applicable


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipients

Maltitol liquid

Hydroxyethylcellulose

Sodium benzoate

Citric acid monohydrate

Sodium citrate

Apple flavouring 5112OIE

Purified water


Go to top of the page
6.2 Incompatibilities

None stated


Go to top of the page
6.3 Shelf life

36 months


Go to top of the page
6.4 Special precautions for storage

Keep tightly closed.

Do not store above 25°C.


Go to top of the page
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.


Go to top of the page
6.6 Special precautions for disposal and other handling

Not applicable


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/0500


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Not applicable


Go to top of the page
10. DATE OF REVISION OF THE TEXT

January 2005



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/13975/SPC/


Active Ingredients/Generics

 
  glycerol