PAROXETINE TABLETS

Hazard statements (CLP)

H318, H361fd, H373, H412

Code

Statements

H318

Causes serious eye damage

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

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 - repeated Category 2 (bones) H373 - May cause damage to exposure organs (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. Hazard summary Caution - Pharmaceutical agent. Causes serious eye damage. May cause damage to organs through prolonged or repeated exposure. Possible reproductive hazard. Prolonged exposure may cause chronic effects. Occupational exposure to the substance or mixture may cause adverse health effects. See section 11 of the SDS for additional information on health hazards. Dangerous for the environment if discharged into watercourses.

2.2 Label elements

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

Contains

CALCIUM PHOSPHATE, DIBASIC, HYDROXYPROPYL METHYL CELLULOSE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, Titanium dioxide

Signal word

Danger

Hazard statements

H318 Causes serious eye damage. H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. H373 May cause 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/fume/gas/mist/vapours/spray. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.

Response

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 or doctor/physician.

Storage

P405 Store locked up.

Disposal

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

Supplemental label elements

12.5534 % of the mixture consists of component(s) of unknown acute dermal toxicity. 6.1534 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 6.1534 % 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 of the SDS for additional information on health hazards.