URUSA- ursodeoxycholic acid capsule 
OASIS TRADING

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

label

URUSA 
ursodeoxycholic acid capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR) URSODIOL250 mg
Inactive Ingredients
Ingredient NameStrength
RIBOFLAVIN (UNII: TLM2976OFR)  
GELATIN (UNII: 2G86QN327L)  
SOYBEAN OIL (UNII: 241ATL177A)  
THIAMINE MONONITRATE (UNII: 8K0I04919X)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize10mm
FlavorImprint Code URSA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0001-160 in 1 BLISTER PACK; Type 0: Not a Combination Product11/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/15/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0001)

Revised: 11/2018
Document Id: 7b0f3ea2-9553-392b-e053-2991aa0ad971
Set id: 7aa650ea-167b-cdd8-e053-2991aa0a7896
Version: 2
Effective Time: 20181119
 
OASIS TRADING