Note: Ingredients listed on restricted chemical lists
EC/CAS
7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
EC/CAS
1317-70-0
Name of the chemical
Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm
Concentration
N/A
EC/CAS
14807-96-6
Name of the chemical
Talc
Concentration
N/A
EC/CAS
9005-25-8
Name of the chemical
Starch
Concentration
N/A
EC/CAS
231-791-2
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
EC/CAS
215-280-1
Name of the chemical
Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm
Concentration
N/A
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
N/A
EC/CAS
238-877-9
Name of the chemical
Talc: Hydrated magnesium silicate
Concentration
N/A
EC/CAS
215-168-2
Name of the chemical
Iron Oxide Red
Concentration
N/A
EC/CAS
232-679-6
Name of the chemical
Starch
Concentration
N/A
General Information
Revision date
2018-09-29
Product name
URSODIOL 500MG TABS BULK
Product Synonyms
Actigall, Arsacol, Cholit-ursan, Delursan, Destolit, Deursil, Litursol, Lyeton, Peptarom, Solutrat,Ursacol, UrSO, Ursobilin, Ursochol, Ursodamor; Ursodeoxycholic Acid
1.2.1 Relevant identified uses
Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and inhibits intestinal
Manufacturer Name
Allergan plc
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
Section 2
2.1 Classification of the substance or mixture
OSHA Regulatory Status This chemical is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.122) Not a dangerous substance or mixture according to the Globally Harmonized System (GHS)
2.2 Label elements
Emergency Overview The product contains no substances which at their given concentration, are considered to be hazardous to health Appearance Tablet Physical state Solid Odor No information available Chemical Name Symptoms Ursodiol USP, micronized Symptoms during therapeutic use may include headache, nausea and dizziness. Other lesser reported symptoms include abdominal irritation and discomfort, diarrhea, gas, vomiting (diarrhea has been associated with overdose), joint and muscleaches and pain, back pain, and upper respiratory, nose and throat irritation, inflammation and infection; allergic or sensitization reactions are reported with pure material. Rare cases of skin eruptions have been reported. POVIDONE USP(PLASDONE K-29-32) Possible eye, skin, gastrointestinal and/or respiratory tract irritation. Possible allergic reaction to material if inhaled, ingested or in contact with skin. Overdose effects from ingestion of large amounts include abdominal cramps, flatulence, and fecal impaction. Chemical Name
Medical Conditions Generally Aggravated by Exposure
Ursodiol USP, micronized Patients with complete biliary obstruction and known hypersensitivity orintolerance to ursodiol or any of the components of the formulation. POVIDONE USP(PLASDONE K-29-32) Known hypersensitivity to this medication
Further information
Unknown Acute Toxicity 24.9% 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
