Ursodiol 250 MG Oral Tablet

1 INDICATIONS AND USAGE Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets, 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )

Cadila Healthcare Limited

FDA Reported Adverse Reactions
`[1] fatigue` `[2] nausea` `[3] dyspnoea` `[4] diarrhoea` `[5] drug ineffective` `[6] dizziness` `[7] headache` `[8] asthenia` `[9] pain` `[10] fall`

4 years ago

OVAL WHITE 1127

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1

URSODIOL Tablets, USP 250 mg

URSODIOL Tablets USP, 250 mg are white to off-white, oval, biconvex, film coated tablets debossed with "1127" on one side and plain on other side and are supplied as follows: NDC 70771-1407-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1407-5 in bottles of 500 tablets 16.2

URSODIOL Tablets, USP 500 mg

URSODIOL Tablets USP, 500 mg are white to off-white, oval, biconvex, film coated tablets debossed with "1128" on one side and breakline on other side. and are supplied as follows: NDC 70771-1408-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1408-5 in bottles of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Half-tablets (scored

URSODIOL 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20ºC to 25ºC (68ºF to 77ºF). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.2) ].

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