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Boots Cough Syrup 3 Months Plus

Marketing Authorization Holder: The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA Trading as: BCM

Authorised
Legal Category

General Sales List

ATC Code

Not classified

Authorization Number

PL 00014/0500

Summary of Product Characteristics

Detailed prescribing information and pharmaceutical guidance from the UK Electronic Medicines Compendium.

Composition

Active and inactive ingredients

| | | | | --- | --- | --- | | **Active ingredient** | **% v/v** | **ml/5ml** | | Glycerol Ph Eur | 15.0 | 0.75 |

Pharmaceutical Form

Dosage form and administration route

Syrup

Clinical Particulars

Therapeutic indications and usage

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.

Pharmacological Properties

Pharmacodynamics and pharmacokinetics

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

Pharmaceutical Particulars

Storage and handling information

6.1 List of excipients Maltitol liquid Hydroxyethylcellulose Sodium benzoate Citric acid monohydrate Sodium citrate Apple flavouring 5112OIE Purified water6.2 Incompatibilities None stated6.3 Shelf life 36 months6.4 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
Last updated: 14/07/2015

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