Ursodiol 300 MG Oral Capsule

INDICATIONS AND USAGE 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. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Amneal Pharmaceuticals NY LLC

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] fatigue` `[4] nausea` `[5] diarrhoea` `[6] headache` `[7] dyspnoea` `[8] adverse drug reaction` `[9] pain` `[10] condition aggravated`

4 years ago

CAPSULE PINK AN 1540

HOW SUPPLIED

URSODIOL capsules USP, 300 mg are supplied as opaque white body and pink cap, imprinted “AN” on one half and “1540” on the other half of the capsules in black. They are available as follows: Bottles of 100: NDC 69238-1540-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in USP. Keep this and all medications out of the reach of children. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 11-2023-02

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Ursodiol 300 MG Oral Capsule

FDA Reported Adverse Reactions [1] drug ineffective [2] off label use [3] fatigue [4] nausea [5] diarrhoea [6] headache [7] dyspnoea [8] adverse drug reaction [9] pain [10] condition aggravated

CAPSULE PINK AN 1540

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] fatigue` `[4] nausea` `[5] diarrhoea` `[6] headache` `[7] dyspnoea` `[8] adverse drug reaction` `[9] pain` `[10] condition aggravated`