Baby Meltus Cough Linctus

1. Name Of The Medicinal Product

Baby Meltus Cough Linctus.

2. Qualitative And Quantitative Composition

Dilute Acetic Acid BP 0.42 ml/5ml.

3. Pharmaceutical Form

Syrup for oral use.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of the irritating and distressing coughs which often accompany colds.

4.2 Posology And Method Of Administration

Oral. To be given slowly. 3 months to one year: half a 5 ml spoonful. Over one year: one 5 ml spoonful. Over two and a half years: two 5 ml spoonfuls. Repeat as necessary every 2 to 3 hours.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Keep out of reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

At the level of acetic acid in this product, none are known.

4.9 Overdose

Not applicable. Treatment: Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Baby Meltus Cough Linctus contains acetic acid - a mild expectorant in a sugar free blackcurrant flavoured demulcent base.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tolu Flavour Solution - sugar free; Sorbitol Solution Non Crystallising; Carmellose Sodium; Imitation Blackcurrant Flavour 500013E; Blackcurrant Flavour C3688; Sodium Saccharin; Methylhydroxybenzoate; Propylhydroxybenzoate; Water.

6.2 Incompatibilities

None.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Amber glass sirop bottle with tamper evident cap with fitted polycone liner in an outer carton containing 100 ml of product. Supplied with a 5ml CE marked polystyrene measuring spoon.

6.6 Special Precautions For Disposal And Other Handling

None known.

7. Marketing Authorisation Holder

Cupal Ltd, Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA, UK

8. Marketing Authorisation Number(S)

PL 0338/0059.

9. Date Of First Authorisation/Renewal Of The Authorisation

9^th October 1986 / 29^th May 2003.

10. Date Of Revision Of The Text

September 2007