1 NAME OF THE MEDICINAL PRODUCT

Asda Children’s Dry Cough Syrup Glycerin Blackcurrant Flavour

Bell’s Children’s Cough Syrup Blackcurrant Flavour

Bell’s Healthcare Children's Dry Cough Glycerin 0.75g/5ml Syrup

Essential Waitrose Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution

Hill’s Balsam Children’s Cough Syrup

Morrisons Children’s Dry Tickly Cough Glycerin 0.75g/5ml Oral Solution Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution Sainsbury’s Children’s Dry Cough 0.75g/5ml Syrup

Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution

Tesco Children’s Dry Cough Syrup

Wilko Tickly Cough 0.75g/5ml Oral Solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

Glycerol    0.75 gm

3    PHARMACEUTICAL FORM

Oral Solution

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

For the symptomatic relief of tickly coughs and sore throats.

4.2.    Posology and method of administration

Adults the Elderly and children over 12 years: 5 to 10ml Children 6 to 12 years: 5ml Children 1 to 5 years: 2.5ml

Sip and swallow slowly three or four times a day.

Contraindications

Hypersensitivity to any of the constituents. Glucose malabsorption syndrome. Glucose intolerance due to sucrase or isomaltase deficiency.

4.4. Special warnings and precautions for use

Keep out of the sight and reach of children.

Shake bottle before use.

Care should be taken in patients with diabetes mellitus.

Interactions with other medicinal products and other forms of interaction

Citric acid may interact with potassium tartrate, carbonates and bicarbonates which , therefore, should not be administered at the same time.

4.6. Pregnancy and lactation

No data are available.

4.7. Effects on ability to drive and use machines

None.

4.8 Undesirable effects

None Known

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

There is no evidence that overdose is harmful.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Glycerin is a demulcent and humectant and soothes the throat.

5.2.    Pharmacokinetic Properties

Pharmacokinetically glycerin when present in a dosage form such as a syrup will exert its desired action locally on the oro-pharynx.

5.3.    Preclinical Safety Data

No relevant information additional to that already contained elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

List of excipients

Sucrose

Liquid Glucose

Citric Acid Anhydrous BP

Blackcurrant Flavour

Anthocyanin

Purified Water

6.2. Incompatibilities

None.

6.3. Shelf Life

36 months in unopened bottle.

6.4. Special Precautions for Storage

Do not store at a temperature exceeding 25^oC. Store in the original container.

6.5 Nature and contents of container

Bottle: White flint or Amber (Type III) glass

Closures: Polypropylene Child resistant closure (CRC) fitted with low density polyethylene EPe/aL/PET liner

OR

Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner

Size: 100 ml, 125 ml, 150 ml, 200 ml.

Not all pack sizes may be marketed 30 ml CE marked polypropylene measuring cup with 2.5 ml, 3.3 ml 4 ml, 5 ml, 7.5 ml, 10 ml, 15 ml, 20 ml and 25 ml graduations.

(May not be included in all marketed products)

6.6. Instruction for Use, Handling and Disposal

None.

7    MARKETING AUTHORISATION HOLDER

Bell, Sons & Co.

Gifford House Slaidburn Crescent Southport Merseyside PR9 9AL

8    MARKETING AUTHORISATION NUMBER(S)

PL 03105/0066

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/05/2008

10    DATE OF REVISION OF THE TEXT

02/01/2015