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


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


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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


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

% v/v

ml/5ml

Glycerol Ph Eur

15.0

0.75


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3. PHARMACEUTICAL FORM

Syrup


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of dry tickly coughs.


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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.


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions.


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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.


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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4.8 Undesirable effects

No adverse effects known.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

None stated.


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5.3 Preclinical safety data

Not applicable


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Maltitol liquid

Hydroxyethylcellulose

Sodium benzoate

Citric acid monohydrate

Sodium citrate

Apple flavouring 5112OIE

Purified water


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6.2 Incompatibilities

None stated


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6.3 Shelf life

36 months


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6.4 Special precautions for storage

Keep tightly closed.

Do not store above 25°C.


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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.


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6.6 Special precautions for disposal and other handling

Not applicable


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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/0500


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Not applicable


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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