Fluoxetine Tablets, USP 60mg

Hazard statements (CLP)

H315, H319, H412

Code

Statements

H315

Causes skin irritation

SECTION 2: Hazards identification

1999/45/EC EMERGENCY OVERVIEW

Product definition

This product is a yellow tablet with no odor

Health hazards

Intact Fluoxetine Hydrochloride Tablets, USP 60mg are not considered to be a health hazard with normal handling. The contents of Fluoxetine Hydrochloride Tablets, USP 60mg may be irritating to the eyes and skin. Effects of exposure to the contents may include tremors, drowsiness, and liver tissue changes. Flammability Hazards: This product is non-flammable. Reactivity Hazards: None known

Environmental hazards

The Environmental effects of this product have not been investigated. Release of this product is not expected to have significant adverse effects in the aquatic environment. US DOT SYMBOLS

Classification according to GHS

Skin Irritant Category 3 Eye Irritant Category 2B Hazardous to Aquatic Environment Category 3

Precautionary statements

H315: Causes skin irritation P262: Do not get in eyes, on skin, or on clothing H319: Causes serious eye irritation P264: Wash hands thoroughly after handling H412: Harmful to Aquatic Life with long lasting effects P273: Avoid release to the environment 2.3 HEALTH HAZARDS OR RISKS FROM EXPOSURE: SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The most significant routes of exposure for this product are by ingestion, inhalation and skin or eye contact. Tablets are intended for human consumption under guidance of a physician. Tablets are not considered hazardous under normal handling procedures. ACUTE: Contents of the tablet may be irritating to skin and eyes. Fluoxetine hydrochloride, the active ingredient, may cause burns or permanent tissue damage to the eyes. Contact dermatitis (rash) has been reported with occupational exposure to fluoxetine hydrochloride. The most common adverse events reported with therapeutic administration include nausea, decreased appetite, anxiety, tremors, drowsiness, and sweating. The most common signs and symptoms associated with non-fatal over-dosage were seizures, drowsiness, nausea, increased heart rate, and vomiting. CHRONIC: Effects of exposure to the contents may include tremors, drowsiness, and liver tissue changes. TARGET ORGANS Acute Eye, Skin Chronic: Liver

2.1 Classification of the substance or mixture

EUROPEAN UNION DIRECTIVES: This product does meet the definition of a hazardous substance or preparation as defined by 29 CFR 1910. 1200 AND the European Union Council Directives 67/548/EEC, 1999/45/EC, 1272/2008/EC and subsequent Directives. EU HAZARD CLASSIFICATION OF INGREDIENTS PER DIRECTIVE 1272/2008/EC: None of the ingredients are classified in Annex VI Substances not listed either individually or in group entries must be self classified. COMPONENT(S) CONTRIBUTING TO CLASSIFICATION(S): Fluoxetine Hydrochloride