1 NAME OF THE MEDICINAL PRODUCT

Asda Dry Tickly Cough Syrup Glycerin Honey & Lemon Flavour Bell's Healthcare Dry Tickly Cough Glycerin 0.75g/5ml Oral Solution Essential Waitrose Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution Morrisons Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution Numark Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution Sainsbury’s Dry Tickly Cough Syrup Glycerin 0.75g/5ml Oral Solution Superdrug Dry Tickly Cough Glycerin 0.75 g/ 5 ml Oral Solution Tesco Dry Tickly Cough Syrup Glycerin Lemon & Honey Flavour The co-operative Dry Tickly Cough Syrup Glycerin 0.75g/5ml Oral Solution Wilko Dry Tickly Cough Glycerin 0.75g/5ml Oral solution

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

Glycerin BP    0.75g

3. PHARMACEUTICAL FORM

Oral solution

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Taken orally 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.

4.3 Contraindications

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

4.4 Special warnings and special precautions for use

Keep out of reach of children.

Shake bottle.

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

It is possible that citric acid ingested in large quantities or frequently may cause gastric irritation, or erosion of dental enamel.

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.

Overdose

There is no evidence that overdose is harmful.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Glycerin is 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

N/A

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose Purified Honey Glucose Liquid Citric Acid Anhydrous BP Lemon Flavour Lime Flavour Sodium Benzoate Purified Water

6.2 Incompatibilities

None

Shelf life

36 months in unopened bottle

6.4 Special precautions for storage

Do not store above 25°C. Keep out of direct sunlight.

6.5 Nature and contents of container

Bottle: White flint or Amber (Type III) glass

Closures: 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, 200 ml and 300 ml.

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)

Not all pack sizes may be marketed

6.6 Instructions for use/handling

None

MARKETING AUTHORISATION HOLDER

Bell. Sons & Co Gifford House Slaidbum Crescent Southport Merseyside PR9 9AL

8. MARKETING AUTHORISATION NUMBER

PL 03105/0057

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/02/2004

10 DATE OF REVISION OF THE TEXT

07/06/2016