Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Amylmetacresol; 2, 4-dichlorobenzyl alcohol
Reckitt Benckiser Ireland Ltd
R02AA; R02AA03
Amylmetacresol; 2, 4-dichlorobenzyl alcohol
600 mcg/1.2 milligram(s)
Lozenge
Product not subject to medical prescription
Antiseptics; dichlorobenzyl alcohol
Marketed
1997-05-02
CUSTOMER INFO: Minimum Point Size = (BOP copy is a minimum of 9pt). 7.00pt 5.3 mm 85% EAN 13 5000167090345 14.2 mm 0 microns N/A 17.0 mm BARCODE INFO Barcode Type: Barcode Number: Magnification: Truncated By: Full Height: Bar Height (Smallest Bar): BWR: Encoded Data: Trident Reference No: ZEN Ref: Action: Brand: Category: Segment Group: Segment: Pack Size: Market/Country: Date: Component Code (2D if applicable) : Parent Technical Packaging Specification: Finished Goods Code: Supply Point: 3rd Party Code Pharmacode No/NE: Edgemark Position: CAD Cam Ref: Printer: Substrate: 1111000011(1986) NA RB Nottingham 3, A, Y 0271552 Strepsils Throatcare Strawberry Sugar Free 16 16Pack RB364449 Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only. STUDIO USE ONLY v2.0 Sm•Art check results: Cutter Guides Technical & Non Printing Items Cutter 2 (if applicable) Guides 2 (if applicable) Multi Packaging Solutions (Nottingham, UK) S-Crt-FB-S1-79x109x21mm-D0069669-(Lottie) TR1551577 Carton Board - White Ireland 26/02/19 B Ryan Reilly 3096654 G=2; O=2; R=0; - RR - 26/02/19 16:51:29 RB Artwork and Print Specification D0069669 Artwork Type: IDM Commercial 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 1 LTH Process Magenta 2 LTH Process Black 3 LTH Braille 4 LTH Varnish-Water Based Emulsion Colours (Carton) RBH Contact: Jillian Buckle Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. S T R E P S I L S S T R AW B E R R Y S U G A R F R E E 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 Read the complete document
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 Read the complete document