Strepsils Strawberry Sugar Free Lozenges Amylmetacresol 600 micrograms 2, 4-Dichlorobenzyl Alcohol 1.2 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amylmetacresol; 2, 4-dichlorobenzyl alcohol

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AA; R02AA03

INN (International Name):

Amylmetacresol; 2, 4-dichlorobenzyl alcohol

Dosage:

600 mcg/1.2 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiseptics; dichlorobenzyl alcohol

Authorization status:

Marketed

Authorization date:

1997-05-02

Patient Information leaflet

CUSTOMER INFO:
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17.0 mm
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1111000011(1986)
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RB Nottingham
3, A, Y
0271552
Strepsils
Throatcare
Strawberry Sugar Free
16
16Pack
RB364449
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Ryan Reilly
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G=2; O=2; R=0; - RR - 26/02/19 16:51:29
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D0069669
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RBH Contact:
Jillian Buckle
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: [phone]
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T B R 1 2 4 2 - D 0 0 6 9 6 6 9 – E n g l i s h A l p h a b e t
LOT:
DO NOT USE AFTER:
16
lozenges
Soothing effective relief for sore throats
_DUAL_ anti-bacterial action
LOZENGES
LOZENGES
Amylmetacresol 600 microgram
2,4-Dichlorobenzyl alcohol 1.2mg
LOZENGES
STRAWBERRY
LOZENGES
STRAWBERRY
® STRAWBERRY S

Summary of Product characteristics

Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Strawberry Sugar Free Lozenges Amylmetacresol 600 micrograms
2, 4-Dichlorobenzyl Alcohol 1.2 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains amylmetacresol 600 micrograms and 2,
4-Dichlorobenzyl alcohol 1.2 mg.
Excipients with known effects:Propylene Glycol 7.30 mg/lozenge.
Isomalt (E 953) 1.83 g (1830 mg)/lozenge.
Maltitol liquid (E 965) 0.458 g (458 mg)/lozenge.
Benzyl Alcohol (present in Strawberry flavour) 0.0028 mg/lozenge.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge
Pink, circular lozenge with a characteristic strawberry taste,
embossed on both sides with strepsils brand icon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Strepsils Sugar Free are indicated for the symptomatic relief of mouth
and throat infections including sore throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms. It is recommended that the
product should be used for a maximum of 3 days.
ADULTS:
One lozenge every 2-3 hours. Do not take more than 12 lozenges in 24
hours.
PAEDIATRIC POPULATION:
CHILDREN OVER 6 YEARS OF AGE: As above for adults.
CHILDREN UNDER 6 YEARS OF AGE:
Not suitable for children under 6 years (see section 4.4)
ELDERLY:
There is no need for dosage reduction in the elderly.
METHOD OF ADMINISTRATION
For oromucosal administration. To be dissolved slowly in the mouth.
4.3 CONTRAINDICATIONS
Strepsils Strawberry Sugar Free Lozenges are contraindicated in
persons who have previously shown hypersensitivity to the
active substances or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product is not recommended for young children due to a risk of
choking.
Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 2 of 5
Consult your doctor if symptoms persist or if anythin