PAXIL CR TABLETS

Hazard statements (CLP)

H302, H318, H335, H361fd, H372, H412

Code

Statements

H302

Harmful if swallowed

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 1 H318 - Causes serious eye damage. Reproductive toxicity (fertility, the unborn Category 2 H361fd - Suspected of damaging child) fertility. Suspected of damaging the unborn child. Specific target organ toxicity - single Category 3 respiratory tract irritation H335 - May cause respiratory exposure irritation. Specific target organ toxicity - repeated Category 1 (bones) H372 - Causes damage to organs exposure (bones) through prolonged or repeated exposure.

Environmental hazards

Hazardous to the aquatic environment, Category 3 H412 - Harmful to aquatic life with long-term aquatic hazard long lasting effects.

2.2 Label elements

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

Contains

HYDROXYPROPYL METHYL CELLULOSE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, Polyvinylpyrrolidone, TALC, NON-ASBESTOS FORM, TRIBEHENIN

Signal word

Danger

Hazard statements

H302 Harmful if swallowed. H318 Causes serious eye damage. H335 May cause respiratory irritation. H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. H372 Causes damage to organs (bones) through prolonged or repeated exposure. H412 Harmful to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust. P261 Avoid breathing vapours. P264 Wash hands thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.

Response

P330 Rinse mouth. P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTRE/doctor/physician.

Storage

P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up.

Disposal

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

Supplemental label elements

12.8 % of the mixture consists of component(s) of unknown acute oral toxicity. 100 % of the mixture consists of component(s) of unknown acute dermal toxicity. 100 % of the mixture consists of component(s) of unknown acute inhalation toxicity. 91.8 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 88.8 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

2.3 Other hazards

Assume that this material is capable of sustaining combustion. Caution - Pharmaceutical agent. See section 11 for additional information on health hazards. See section 11 of the SDS for additional information on health hazards.