Reckitt Benckiser Ireland Limited

Strepsils Cool Lozenges

Each lozenge contains:

2, 4-Dichlorobenzyl alcohol 1.2 mg

Amylmetacresol 0.6mg

For excipients, see 6.1

Lozenge

White to pale yellow coloured lozenge with a characteristic taste of cool mint, embossed on both sides with Strepsils brand icon.

For mouth and throat infections

Adults and children: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Elderly: There is no need for dosage reduction in the elderly.

Not suitable for children under 12 years.

For oral administration.

Hypersensitivity to any of the ingredients.

Keep all medicines out of reach of children.

Consult your doctor if symptoms persist or if anything unusual happens

Patients with rare hereditary problems of fructose intolerance, glucose-glalctose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.

Not suitable for children under 12 years.

No clinically significant interactions are known

The safety of Strepsils Cool has not been established, therefore not recommended.

No adverse effects are known.

Occasionally hypersensitivity reactions.

Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

2, 4-Dichlorobenzyl alcohol and amymetacresol have antiseptic properties.

None stated.

Not applicable.

Xylitol

Cool Mint Sensation Flavour (contains polyethylene glycol)

Levomenthol

Spearmint

Eucalyptus oil

Liquid Sucrose

Liquid Glucose

Not applicable.

3 years (for lozenges packed in blister strips within a carton).

36 months for lozenges packed in polypropylene tube, with an in use shelf-life of 'use within 3 months of opening.

Do not store above 25°C.

Polypropylene tube - Do not store above 25°C. Keep the tube tightly closed in order to protect from moisture.

A blister push-through tray of PVC/PVDC laminate heat-sealed to aluminium foil.

24 lozenges (each blister tray contains 12 lozenges packed in a carton).

8 lozenges (one tray contains 8 lozenges in a wrap around cardboard carton with tamper-evident seal).

2 lozenges pack.

An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc). The tube contains 10 lozenges.

Not all pack sizes may be marketed.

Not special requirements.

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24

PA 979/38/1

25th January 1985/25^th January 2005

July2009