URUSA- ursodeoxycholic acid capsule

URUSA by

Drug Labeling and Warnings

URUSA by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ursodeoxycholic Acid

PURPOSE

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

Keep out of reach of children

INDICATIONS & USAGE

1 capsule once, three times a day

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

thiamine nitrate, Riboflavin, gelatin, soybean oil

DOSAGE & ADMINISTRATION

For oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

URUSA 
ursodeoxycholic acid capsule

Product 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)