1. Name Of The Medicinal Product
Boots Dry Cough Relief Oral Solution
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Oral Solution
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of irritating, tickling dry coughs and sore throats.
4.2 Posology And Method Of Administration
Adults and children over 5 years: 10 ml
Children 1 - 5 years: 5 ml
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
Elderly: There is no need for dosage reduction in the elderly.
For oral administration.
4.3 Contraindications
Hypersensitivity or intolerance to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Diabetics should take note of the carbohydrate contents of this product.
Do not give to children under one year.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions known.
4.6 Pregnancy And Lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
No adverse effects would be anticipated.
4.9 Overdose
Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Glycerin and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.
5.2 Pharmacokinetic Properties
Glycerin is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric acid monohydrate
Sodium benzoate
Cough Syrup 513277
Black Treacle
Liquid glucose
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: A wadless polypropylene tamper evident cap.
Pack size: 200ml.
or
An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal LDPE/EPE/LDPE) liner.
Pack size: 125ml.
or
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Pack size: 150ml or 300ml
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
Trading as: BCM
8. Marketing Authorisation Number(S)
PL 00014/0550
9. Date Of First Authorisation/Renewal Of The Authorisation
13 December 1995 / 12 December 2000
10. Date Of Revision Of The Text
December 2010
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