OTC - ACTIVE INGREDIENT SECTION
Ursodeoxycholic Acid
Ursodeoxycholic Acid
Improve liver function of chronic liver disease
Improvement of the following symptoms due to hepatic dysfunction: physical fatigue, general boredom
Keep out of reach of children
1 capsule once, three times a day
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.
thiamine nitrate, Riboflavin, gelatin, soybean oil
For oral use only
| Class | Version | Type | Effective |
|---|---|---|---|
| URSODIOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1ab35ce6-695f-4d1d-43b4-c16fd63c1674 | Product name | 3 | 20250317 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| 74e0d644-a165-40ec-b881-1b01c8aa68a4 | Product name | 1 | 20201006 |
| 24881a03-c677-697f-03b9-66e93689fade | Product name | 2 | 20180724 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72689-0001-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f9b8-f424-e053-dadaa90a57ce | 7aa650ea-167b-cdd8-e053-2991aa0a7896 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72689-0001-1 | URUSA | 60 in 1 BLISTER PACK | CAPSULE | 60 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72689-0001 | URUSA (URSODEOXYCHOLIC ACID) CAPSULE [OASIS TRADING] | 2 | Legacy NDC, 1 package rows | 20181120_7aa650ea-167b-cdd8-e053-2991aa0a7896.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72689-0001 | 72689-0001-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| RIBOFLAVIN | TLM2976OFR | IACT |
| GELATIN | 2G86QN327L | IACT |
| URSODIOL | 724L30Y2QR | ACTIB |
| SOYBEAN OIL | 241ATL177A | IACT |
| THIAMINE MONONITRATE | 8K0I04919X | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7b0f3ea2-9553-392b-e053-2991aa0ad971 | 7aa650ea-167b-cdd8-e053-2991aa0a7896 | 2018-11-19 | Warnings | 7b0f3ea2-9553-392b-e053-2991aa0ad971 7aa650ea-167b-cdd8-e053-2991aa0a7896 |
Adverse event summaries are temporarily unavailable. Other product information remains available.