Buttercup Syrup (Chefaro UK Ltd)

1. Name Of The Medicinal Product

Buttercup Syrup

2. Qualitative And Quantitative Composition

Squill Liquid Extract 0.062% v/v

Capsicum Tincture 0.05% v/v

3. Pharmaceutical Form

Oral Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

For coughs, colds, sore throats, hoarseness.

Route of administration: oral.

4.2 Posology And Method Of Administration

Adults: Two 5 ml spoonfuls three times a day and on retiring, when the cough is troublesome.

Children (over 2 years of age): One 5 ml spoonful three times a day and on retiring, when the cough is troublesome.

Children (under 2 years of age): Not recommended.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor. Keep all medicines out of the reach and sight of children.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

As with all medicines, caution is required. If in doubt, consult your medical adviser.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

None known.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Traditional mixed constituents, syrup based remedy providing symptomatic relief by virtue of demulcent properties, a mild expectorant action and an aromatic “warming” flavour.

5.2 Pharmacokinetic Properties

None available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acacia Powder

Caramel Colour (E150)

Ethanol 96%

Levomenthol

Clove Oil

Peppermint Oil

Sodium methyl hydroxybenzoate (E219)

Sodium propyl hydroxybenzoate (E217)

Aniseed Flavour

Purified Water

Carmoisine (E122)

Sunset Yellow (E110)

Strong Ginger Tincture

Acetic Acid (80%)

Saccharin Sodium

Syrup (fructose, glucose and sucrose)

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months (unopened).

28 days (after first opening the bottle).

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

75 ml bottle: R.O.P.P. aluminium cap.

150 ml bottle: R.O.P.P. aluminium cap.

200 ml bottle: White fluted plastic cap with viskring and aluminium foil wad.

All sizes are in clear glass flat bottles, with straight sides. Caps are twist off.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Chefaro UK Ltd,

4^th Floor, Hamilton House,

Mabledon Place, Bloomsbury,

LONDON, WC1H 9BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 02855/0024

9. Date Of First Authorisation/Renewal Of The Authorisation

30th November 2004

10. Date Of Revision Of The Text

14^th November 2010