- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
URUSA
ursodeoxycholic acid capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR) URSODIOL 250 mg Inactive Ingredients Ingredient Name Strength RIBOFLAVIN (UNII: TLM2976OFR) GELATIN (UNII: 2G86QN327L) SOYBEAN OIL (UNII: 241ATL177A) THIAMINE MONONITRATE (UNII: 8K0I04919X) Product Characteristics Color yellow Score no score Shape OVAL Size 10mm Flavor Imprint Code URSA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0001-1 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/15/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0001)