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ASDA CHLIDRENS TICKLY COUGH SYRUP

Active substance(s): CITRIC ACID MONOHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Paediatric Simple Linctus B.P.
Asda Chlidren’s Tickly Cough Syrup.
AAH Warrington/ASPAR Pharmaceuticals Limited Asda Children’s Tickly
Cough Syrup (ASDA Stores)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate B.P. 0.03125 g/5 ml dose

3

PHARMACEUTICAL FORM
Oral solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of the symptoms of cough.

4.2

Posology and method of administration
Adults and the elderly
The product is intended for children under 12 years. An adult formulation is
available.
Children under 12 years
One or two 5 ml spoonfuls to be given 3 or 4 times a day.

4.3

Contraindications
No significant contraindications have been reported; however it should be
noted that the sucrose content is 85.3% and the product may be unsuitable for
the diabetic patient.

4.4

Special warnings and precautions for use
Store at a temperature not exceeding 25oC.
If symptoms persist a doctor should be consulted.

4.5

Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.

4.6

Fertility, pregnancy and lactation
The product is intended for paediatric use.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
No significant other undesirable effects have been reported.

4.9

Overdose
Overdosage is unlikely to present a significant risk but if it does occur then the
treatment consists of general supportive therapy and may include gastric
lavage.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Citric acid monohydrate imparts a sharp taste to the product which acts as a
demulcent; though it may be a placebo effect some patients believe that
preparations, such as Paediatric Simple Linctus B.P., relieve a dry tickling
cough.

5.2

Pharmacokinetic properties
Citric acid monohydrate is metabolised to carbon dioxide and water in the
Krebs cycle.

5.3

Preclinical safety data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Nipasept sodium
Water potable
Amaranth
Chloroform
Ethanol 96%
Anise oil
Glycerol
Syrup

6.2

Incompatibilities
Though the product is acidic in nature and may exhibit incompatibilities with
alkaline products and constituents no significant major incompatibilities have
been reported.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store below 25oC.

6.5

Nature and contents of container
Dispensing packs
2000 ml plastic bottle with a plastic screw cap with an aluminium foil lined
EPE liner.
500 ml plastic bottle with a wadless plastic screw cap.
OTC/Patient packs
100 ml or 200 ml amber glass bottle with a plastic “Jaycap” closure.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
Unit 7,
Hardicher Street,
Manchester,
M19 2RB
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0028

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18th May 2005

10

DATE OF REVISION OF THE TEXT
20/09/2006

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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