FDA Label for Urusa
View Indications, Usage & Precautions
Urusa Product Label
The following document was submitted to the FDA by the labeler of this product Oasis Trading. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Ursodeoxycholic Acid
Otc - Purpose
Improve liver function of chronic liver disease
Improvement of the following symptoms due to hepatic dysfunction: physical fatigue, general boredom
Otc - 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
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