Strepsils Cool

Amylmetacresol BP 0.6mg

2,4-Dichlorobenzyl alcohol HSE 1.2mg

For excipients, see 6.1

White to pale yellow coloured lozenge with a characteristic taste of cool mint and the Strepsils brand icon intagliated on both sides

For the symptomatic relief of mouth and throat infections.

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

Children over 12 years: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 8 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 the reach of children.

If symptoms persist consult your doctor.

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

No clinically significant interactions are known.

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

No adverse effects are known.

Occasional hypersensitivity reactions.

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

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

Pharmacokinetically the active ingredients, when present in a dosage form such as a lozenge, will exert their desired effect locally on the oropharynx.

There are no preclinical data of relevance to the prescriber, which are additional to that included in other sections of the SPC.

Xylitol,

Cool Mint Sensation Flavour (contains propylene glycol),

Levomenthol,

Spearmint,

Eucalyptus oil,

Liquid Sucrose,

Liquid Glucose,

Not applicable.

36 months for lozenges packed in blister strips within a carton.

Do not store above 25°C.

A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister.

The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36, 40, 44, 48 and 720 lozenges in a cardboard carton or a flow wrap composed of PET/aluminium foil/polyethylene

A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges in a wrap around cardboard carton with tamper-evident seal.

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.

20 lozenges consisting of a bundled pack of 2 tubes of 10 lozenges each.

Not all pack sizes may be marketed.

Not applicable.

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

PL 00063/0469

11/02/2010

11/02/2010

(IF APPLICABLE)

(IF APPLICABLE)