1. Name Of The Medicinal Product
Benylin Children's Apple Flavour Cough Syrup or CalCough Infant Syrup
2. Qualitative And Quantitative Composition
Active ingredient |
| ml/5ml |
| 15.0 | 0.75 |
3. Pharmaceutical Form
Syrup
A clear colourless syrup with an apple flavour.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of dry tickly coughs.
4.2 Posology And Method Of Administration
Oral use.
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.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
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
If symptoms persist for more than 3 days consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant drug interactions.
4.6 Pregnancy And Lactation
Not applicable.
4.7 Effects On Ability To Drive And Use Machines
No or negligible influence.
4.8 Undesirable Effects
Maltitol may have a mild laxative effect.
4.9 Overdose
Overdosage with this product may possibly cause diarrhoea. Treatment should be symptomatic.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The ATC code is R05FB01.
Glycerol has demulcent properties and may possibly block sensory cough receptors in 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 oxidized to carbon dioxide and water. It may also be excreted in the urine unchanged.
5.3 Preclinical Safety Data
Not applicable
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maltitol liquid (E965)
Hydroxyethylcellulose
Sodium benzoate
Citric acid monohydrate
Sodium citrate
Apple flavouring 5112OIE
Purified water
6.2 Incompatibilities
None stated
6.3 Shelf Life
3 years
6.4 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 and 2.5 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 and 2.5 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
Not applicable
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0168
9. Date Of First Authorisation/Renewal Of The Authorisation
19 March 2009
10. Date Of Revision Of The Text
03 October 2009
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