URUSA (URSODEOXYCHOLIC ACID) CAPSULE [OASIS TRADING]

URUSA (URSODEOXYCHOLIC ACID) CAPSULE [OASIS TRADING]
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NDC 72689-0001-1
Set ID 7aa650ea-167b-cdd8-e053-2991aa0a7896
Category HUMAN OTC DRUG LABEL
Packager OASIS TRADING
Generic Name
Product Class
Product Number
Application Number
  • 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)

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