LAMICTAL ORALLY DISINTEGRATING TABLETS (ODT) TABLETS

Hazard statements (CLP)

H302

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. Hazard summary Harmful if swallowed. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

2.2 Label elements

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

Contains

Calcium carbonate, HYDROXYPROPYL CELLULOSE, LAMOTRIGINE

Signal word

Warning

Hazard statements

H302 Harmful if swallowed.

Prevention

P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using this product.

Response

P330 Rinse mouth.

Storage

Not available.

Disposal

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

Supplemental label elements

10.9 % of the mixture consists of component(s) of unknown acute oral toxicity. 55.65 % of the mixture consists of component(s) of unknown acute dermal toxicity. 16.05 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 14.86 % 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.