URUSA

Manufacturer
OASIS TRADING
Effective date
2018-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:19

Label at a glance#

ProductURUSA
Active ingredientURSODIOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ursodeoxycholic Acid

OTC - PURPOSE SECTION

Improve liver function of chronic liver disease

Improvement of the following symptoms due to hepatic dysfunction: physical fatigue, general boredom

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

1 capsule once, three times a day

WARNINGS SECTION

Do not take this medicine if

■ Patients with hypersensitivity to this component ■ Patients with severe biliary obstruction ■ Fulminant hepatitis (may aggravate symptoms) ■ Radiopaque calcified gallstone Patient ■ Non-functional gallbladder patient, acute cholecystitis ■ Pregnant or pregnant women and lactating woman ■ Pediatric ■ Renal disease patient ■ Patient with peptic ulcer (acute gastroduodenal ulcer)

■ Patients with colon and small intestine such as Crohn's disease .

Do not take the following medicines while taking this medicine.

■ there is a risk of increasing the action of the following drugs: Oral diabetes (tolbutamide) ■ The following medications interfere with the absorption of this drug : cholestyramine, cholestipol, Antacids containing ■ Avoid using drugs that reduce cholesterol in the bile (eg estrogen-containing oral contraceptives) or drugs that reduce blood cholesterol

Consult a doctor, dentist or pharmacist before taking this medicine

■ Patients with severe pancreatic disease (may cause worsening of the original disease) ■ Patients with gallstones in the bile ducts (can cause cholestasis due to dysfunction) ■ Varicose bleeding, hepatic coma, ascites, Patients with diabetes

Stop taking this drug immediately and consult a doctor, dentist, or pharmacist if you have any of the following conditions: Whenever possible, bring this attached document with you.

■ Digestive system: Sometimes diarrhea, nausea, vomiting, infrequent abdominal pain, constipation, heartburn, and stomach discomfort may occur. ■ Hypersensitivity: Occasionally itching, rare rashes may occur ■ Interstitial pneumonia: If you develop fever, cough, dyspnea, or interstitial pneumonia accompanied by abnormal chest X-ray, discontinue use and consult your doctor, dentist or pharmacist.

INACTIVE INGREDIENT SECTION

thiamine nitrate, Riboflavin, gelatin, soybean oil

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
URSODIOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72689-0001-12020-01-31C16284748780-19d75b9d0-f9b8-f424-e053-dadaa90a57ce7aa650ea-167b-cdd8-e053-2991aa0a7896

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0001-1URUSA60 in 1 BLISTER PACKCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0001URUSA (URSODEOXYCHOLIC ACID) CAPSULE [OASIS TRADING]2Legacy NDC, 1 package rows20181120_7aa650ea-167b-cdd8-e053-2991aa0a7896.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72689-000172689-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7b0f3ea2-9553-392b-e053-2991aa0ad9717aa650ea-167b-cdd8-e053-2991aa0a78962018-11-19WarningsExact identifier
spl id: 7b0f3ea2-9553-392b-e053-2991aa0ad971
spl set id: 7aa650ea-167b-cdd8-e053-2991aa0a7896

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.