Label: URUSA- ursodeoxycholic acid capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 19, 2018

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  • 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

    label

  • INGREDIENTS AND APPEARANCE
    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)