Note: Ingredients listed on restricted chemical lists
EC/CAS
69-65-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
EC/CAS
200-711-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
General Information
Revision date
2019-07-16
Product name
SAPHRIS
Product Synonyms
Asenapine Sublingual Tablets
1.2.1 Relevant identified uses
Schizophrenia in adults. Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age o Adjunctive
Manufacturer Name
Allergan plc
Emergency telephone
Call CHEMTREC Day or Night
Icons in SDS
Company Information
company name
Allergan plc
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@Allergan.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H351, H361
Hazard statements
Code
Statements
H351
Suspected of causing cancer
Section 2
2.1 Classification of the substance or mixture
OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Carcinogenicity Category 2 Reproductive toxicity Category 2
2.2 Label elements
Emergency Overview Warning
Hazard statements
H351 - Suspected of causing cancer H361 - Suspected of damaging fertility or the unborn child Appearance Tablet Physical state Solid Odor No information available Chemical Name Symptoms Asenapine The most common adverse events associated with asenapine were restlessness, decreased sensitivity of the mouth, sleepiness, dizziness, and weight increase. Chemical Name
Medical Conditions Generally Aggravated by Exposure
Asenapine Contradictions include severe hepatic impairment and hypersensitivity to SAPHRIS (asenapine), or to any components in the formulation.
Precautionary statements
P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant
Further information
Unknown Acute Toxicity 81% of the mixture consists of ingredient(s) of unknown toxicity Over the counter drugs in their solid form are considered exempt under the criteria of the Federal OSHA Hazard Communication Standard 20 CFR 1910.1200. However, in an industrial setting where a component's occupational exposure limit may be surpassed, than can be considered hazardous