Simple Linctus BP (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Simple Linctus BP

2. Qualitative And Quantitative Composition

Citric acid monohydrate BP 125mg per 5ml.

3. Pharmaceutical Form

Linctus

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of the symptoms of coughs.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults, the elderly and children over 12 years: one 5ml spoonful, repeated up to four times per day.

Children under 12 years: not recommended.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Keep out of the reach of children.

Not suitable for children under 12 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No adverse effects are known for the product, however as with all medicines use should be avoided during pregnancy unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

Overdose with this preparation is unlikely to occur due to the low concentrations of the ingredients, however, in the event, treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

None stated.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chloroform BP, anise oil BP, ethanol (96%) BP, glycerol BP, purified water BP and syrup BP.

6.2 Incompatibilities

None.

6.3 Shelf Life

100ml:	12 months unopened. Discard 2 months after first opening.
200ml:	12 months unopened. Discard 2 months after first opening.
500ml:	12 months unopened. Discard 2 months after first opening.
2000ml:	12 months unopened. Discard 2 months after first opening.

6.4 Special Precautions For Storage

Store below 25°C.

The following phrases to appear on the 2 litre pack. Do not store part full bottles. Pre-pack in tightly closed dispensing containers once opened.

6.5 Nature And Contents Of Container

100ml:	Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner
200ml:	Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner
500ml:	Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner.
2000ml:	Amber glass bottle with plastic cap and liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0032

9. Date Of First Authorisation/Renewal Of The Authorisation

21.04.99

10. Date Of Revision Of The Text

2^nd February 2001/26^th July 2004

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable