Note: Ingredients listed on restricted chemical lists
EC/CAS
69-65-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
EC/CAS
9005-25-8
Name of the chemical
Starch
Concentration
N/A
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
General Information
Revision date
2019-01-17
Product name
Fluoxetine Tablets, USP 60mg
Product Synonyms
Fluoxetine Tablets, 60mg USP
Chemical name
(±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p- tolyl)oxy]propylamine hydrochloride
Manufacturer Name
ScieGen Pharmaceuticals, Inc
Icons in SDS
Company Information
company name
ScieGen Pharmaceuticals, Inc
Section 2
SECTION 2: Hazards identification
1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC) 1272/2008 LABELING AND
2.1 Classification of the substance or mixture
According to Article 1, item 5 (a) of CLP Regulation (EC) 1272/2008, medicinal products in the finished state for human use, as defined in 2001/83/EC, are excepted from classification and other criteria of 1272/2008. EU LABELING/CLASSIFICATION: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. EMERGENCY OVERVIEW: Product Description: This product consists of a hard gelatin capsules in color combinations noted in Section 1 or blue oval tablets. Health Hazards: In the workplace, exposure from dusts of capsules or tablets has the potential for irritation of contaminated skin or eyes. Non-therapeutic ingestion may be harmful. May cause adverse central nervous system effects. Chronic ingestion may cause serious or fatal systemic toxicity. Ingestion may cause allergic reactions. In therapeutic use, the most common adverse effects have been headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness. As a selective serotonin reuptake inhibitor, this material may cause harm to the fetus. These effects may be possible as a result of workplace exposure. See Section 11 (Toxicological Information) for more information on possible therapeutic use effects. Flammability Hazards: This product is combustible and can ignite if highly heated or if exposed to direct flame. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides). Reactivity This product is not reactive.
Environmental hazards
May cause harm to aquatic organisms if accidentally released. All environmental release should be avoided. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.
