24 HR Alfuzosin hydrochloride 10 MG Extended Release Oral Tablet

1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tabletsare not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.

sun pharmaceutical industries, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] dyspnoea` `[3] fatigue` `[4] nausea` `[5] off label use` `[6] diarrhoea` `[7] headache` `[8] pyrexia` `[9] febrile neutropenia` `[10] pneumonia`

4 years ago

ROUND WHITE 956

4 years ago

956 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

ALFUZOSIN HYDROCHLORIDE extended-release tablets, USP 10 mg are available as white to off white, round shaped, biconvex, uncoated tablet debossed with ‘956’ on one side and plain on other side.

ALFUZOSIN HYDROCHLORIDE extended-release tablets are supplied as follows: Bottles of 30 with child-resistant cap…..................... NDC 47335-956-83 Bottles of 90 with child-resistant cap......................... NDC 47335-956-81 Bottles of 100 with child-resistant cap ….................. NDC 47335-956-88 Bottles of 100 ………………………………................... NDC 47335-956-08 Bottles of 1,000 ……………………………..….............. NDC 47335-956-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep

ALFUZOSIN HYDROCHLORIDE extended-release tablets out of reach of children. Dispense in a tight, light-resistant container as defined in the USP.

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