This information is intended for use by health professionals

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




Excipient with known effect: Maltitol liquid (E965)

For the full list of excipients, see section 6.1

3. Pharmaceutical form


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


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.

Method of administration

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the ingredients listed in section 6.1.

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 Fertility, 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.

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:

4.9 Overdose

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other cough suppressants and expectorants, ATC code: 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)


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

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


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

19 April 2016