- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Benylin Children's Apple Flavour Cough Syrup or CalCough Infant Syrup or Benylin Infant's Cough Syrup
2. Qualitative and quantitative composition
|Active ingredient||% v/v||ml/5ml|
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.
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
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. 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
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
6. Pharmaceutical particulars
6.1 List of excipients
Maltitol liquid (E965) Hydroxyethylcellulose Sodium benzoate Citric acid monohydrate Sodium citrate Apple flavouring 5112OIE Purified water
6.3 Shelf life
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
7. Marketing authorisation holder
McNeil Products LimitedFoundation ParkRoxborough WayMaidenheadBerkshire SL6 3UGUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
19 March 2009
10. Date of revision of the text
25 June 2015
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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