Ursodiol Tablets USP 250mg and 500 mg

Hazard statements (CLP)

H361

Code

Statements

H361

Suspected of damaging fertility or the unborn child

SECTION 2: Hazards identification

GHS Classification Hazard Classification of chemical mixture Not classified as Hazardous.

Signal word

WARNING

Hazard statements

Suspected of damaging fertility or the unborn child.

Additional information

Short Term Not Available Long Term Not Available

2.2 Label elements

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: Ursodiol USP: Symptoms: 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,

Precautionary statements

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: 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: Ursodiol USP

Medical Conditions Generally Aggravated by Exposure

Patients with complete biliary obstruction and known hypersensitivity or intolerance to Ursodiol or any of the components of the formulation. POVIDONE USP: Known hypersensitivity to this medication Storage/Disposal Keep containers tightly closed in a dry, cool and well-ventilated place. Store away from incompatible materials

EU Classification

Not available

Classification (GHS-US)

Not available