Capsule

Ursodiol

Strength: 300mg Count: 50

NDC

50268-797-15

Class

Brand Name

Actigall

Imprint Code

AN;1540

Color(s)

PINK (pink cap and opaque white body)

Shape

CAPSULE

Score

no score

Case Count

Inactive Ingredients

Colloidal silicon dioxide, gelatin, iron oxide red, magnesium stearate, starch (biological source: maize), titanium dioxide and water. Each capsule is imprinted with black pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, purified water, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

Indications and Usage

1. Ursodiol capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol capsules beyond 24 months is not established. 2. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

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