ZYBAN SUSTAINED RELEASE TABLETS

GSK UK

Revision date : 2022-10-28

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GHS07 GHS09
Health risk rating 3
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

232-674-9/9004-34-6

Name of the chemical

cellulose

Concentration

40-50

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

5-10

EC/CAS

236-675-5/13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

3-5 022-006-

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

≤1

General Information

Revision date

2022-10-28

Product name

ZYBAN SUSTAINED RELEASE TABLETS

Product Synonyms

ZYBAN 150MG PROLONGED-RELEASE TABLETS * ZYBAN 150MG TABLETS * ZYBAN SR

Emergency telephone

VERISK 3E GLOBAL INCIDENT RESPONSE

Icons in SDS

GHS07 T050

Company Information

company name

GSK UK

e-mail address of the competent person responsible for the Safety Data Sheet

msds@gsk.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H302, H319, H400, H410

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

2.1 Classification of the substance or mixture

The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.

EU Classification

Regulation (EC) No 1272/2008 as amended

Health hazards

Acute toxicity, oral Category 4 H302 - Harmful if swallowed. Serious eye damage/eye irritation Category 2 H319 - Causes serious eye irritation.

Environmental hazards

Hazardous to the aquatic environment, acute Category 1 H400 - Very toxic to aquatic life. aquatic hazard Hazardous to the aquatic environment, Category 1 H410 - Very toxic to aquatic life long-term aquatic hazard with long lasting effects.

2.2 Label elements

Label according to Regulation (EC) No. 1272/2008 as amended

Contains

BUPROPION HYDROCHLORIDE, HYDROXYPROPYL METHYL CELLULOSE, L-CYSTEINE HYDROCHLORIDE MONOHYDRATE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, Titanium dioxide

Signal word

Warning

Hazard statements

H302 Harmful if swallowed. H319 Causes serious eye irritation. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects.

Prevention

P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P280 Wear eye protection/face protection.

Response

P330 Rinse mouth. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313 If eye irritation persists: Get medical advice/attention. P391 Collect spillage.

Storage

Not available.

Disposal

P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

Supplemental label elements

46,3 % of the mixture consists of component(s) of unknown acute oral toxicity. 94,1 % of the mixture consists of component(s) of unknown acute dermal toxicity. 60,3 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 60,3 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

2.3 Other hazards

Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

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