Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Amylmetacresol; 2, 4-dichlorobenzyl alcohol; Vitamin c
Reckitt Benckiser Ireland Ltd
R02AA; R02AA03
Amylmetacresol; 2, 4-dichlorobenzyl alcohol; Vitamin c
0.6 mg/1.2 mg/100 milligram(s)
Lozenge
Product not subject to medical prescription
Antiseptics; dichlorobenzyl alcohol
Marketed
1985-09-24
4.9 mm 85% EAN 13 5000167070194 14.6 mm 0 microns N/A 17.4 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: 1111111011(2042) NA RB Nottingham 1, X, Y, Z 0271100 Strepsils Throatcare Orange Vitamin C 24 24Pack RB364530 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-Flipped-79x109x21mm-D0278923-(Lottie) TR1551733 Carton Board - White Ireland 12/03/19 C Siobhan Eyre 3096658 G=2; O=2; R=0; - SE - 12/03/19 08:19:26 RB Artwork and Print Specification D0278923 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 Varnish-Water Based Emulsion 2 LTH Process Black 3 LTH PANTONE 1665 C 4 LTH Process Yellow 5 LTH Process Cyan 6 LTH Braille 7 LTH Emboss 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. (Refers to the “with” within Orange with Vitamin C Lozenges on the SOPs, everything else is a minimum of 7pt. BOP copy is min 8.5pt). CUSTOMER INFO: Minimum Point Size = S t r e p s i l s O ra n g e w i t h Vi t a m i n C T B R 7 4 7 - D 0 2 7 8 9 2 3 – E n g l i s h A l p h a b e t 6.49pt LOT: DO NOT USE AFTER: 24 lozenges Soothing effective relief for sore throats _DUA Lestu allt skjalið
Health Products Regulatory Authority 16 July 2021 CRN00C5NY Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Orange with Vitamin C Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Vitamin C 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 0.6 mg Amylmetacresol, 1.2 mg 2, 4-Dichlorobenzyl Alcohol and 100 mg Vitamin C (as Ascorbic Acid and Sodium Ascorbate). Excipients with known effects: Glucose 0.97 g (968 mg)/lozenge. Sucrose 1.44 g (1438 mg)/lozenge. Propylene glycol 3 mg/lozenge. Wheat Starch (containing gluten present in liquid glucose) 19.36 micrograms/lozenge. Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.124 ppm/lozenge. Orange flavour fragrances containing citral, citronellol, d-Limonene, geraniol and linalool. Colouring agents Ponceau 4R (E124) and Sunset yellow (E110). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge An orange flavoured and coloured circular lozenge. Embossed on both sides with strepsils brand icon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of mouth and throat infection. 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 populations Children over 6 years of age: As above for adults. Children under 6 years of age: Notsuitable 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. Health Products Regulatory Authority 16 July 2021 CRN00C5NY Page 2 of 6 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Patients with rare hereditary problems of fructose intolerance Lestu allt skjalið