This information is intended for use by health professionals

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

2. Qualitative and quantitative composition

Active ingredient

% v/v

ml/5ml

Glycerol Ph Eur

15.0

0.75

3. Pharmaceutical form

Syrup

4. Clinical particulars
4.1 Therapeutic indications

For the relief of dry tickly coughs.

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.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

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.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions.

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.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Immune system disorder: hypersensitivity reactions, including anaphylaxis.

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.

4.9 Overdose

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

Not applicable

6. Pharmaceutical particulars
6.1 List of excipients

Maltitol liquid

Hydroxyethylcellulose

Sodium benzoate

Citric acid monohydrate

Sodium citrate

Apple flavouring 5112OIE

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

36 months

6.4 Special precautions for storage

Keep 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.

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.

6.6 Special precautions for disposal and other handling

Not applicable

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

8. Marketing authorisation number(s)

PL 00014/0500

9. Date of first authorisation/renewal of the authorisation

Not applicable

10. Date of revision of the text

14 July 2015