Dry Cough Syrup
1. Name of the medicinal product
Asda Children’s Dry Cough Syrup Glycerol 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 Dry Tickly Cough 0.75g/5ml Oral Solution
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.
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 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.
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.
6.1 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 25oC. Store in the original 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.
Bell, Sons & Co.
Gifford House Slaidbum Crescent Southport Merseyside PR9 9AL
8
9
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MARKETING AUTHORISATION NUMBER(S)
PL 03105/0066
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/05/2008