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1. Name Of The Medicinal Product


2. Qualitative And Quantitative Composition

Each pastille contains menthol 16.0mg BP

3. Pharmaceutical Form


4. Clinical Particulars 4.1 Therapeutic Indications

Symptomatic relief of sore throats, coughs, colds, catarrh and nasal congestion.

4.2 Posology And Method Of Administration

Allow one pastille to dissolve slowly in the mouth as required.

Maximum daily dose : Adults - 15 pastilles; children aged 6 to 12 years - 10 pastilles; children aged under 6 years - 5 pastilles.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Hypersensitivity to the product is a possible side effect. Contact dermatitis may occur with menthol products.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety in pregnancy and lactation has not been established. However menthol-containing products have been used for many years with no ill effect.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Systemic effects due to overdosage are most unlikely.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Menthol in pastille formulation relieves catarrh and other symptoms associated with colds.

5.2 Pharmacokinetic Properties

Menthol is excreted in the urine and bile as a glucuronide.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Modified starch, antifoam 1510, sucrose, liquorice extract powder, liquid glucose (80%) solid (1963); peppermint oil; benzoin; water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Once opened keep in a cool dry place.

6.5 Nature And Contents Of Container

PVC blister packs with aluminium seal in a cardboard box. Packs contain 3, 8, 24, 36 or 48 pastilles.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Schering-Plough Ltd

Shire Park

Welwyn Garden City




8. Marketing Authorisation Number(S)

PL 0201/0104

9. Date Of First Authorisation/Renewal Of The Authorisation

5 May 1988 / 5 May 1993

10. Date Of Revision Of The Text

November 1998

11. Legal Status







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