Alfuzosin hydrochloride 24 HR Alfuzosin hydrochloride 10 MG Extended Release Oral Tablet

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

Exelan Pharmaceuticals Inc.

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

9 years ago

ROUND WHITE IG 302

9 years ago

IG 302 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

ALFUZOSIN HYDROCHLORIDE extended-release tablets, USP 10 mg are available as off white, round, biconvex tablets debossed with 'IG' on one side and "302" on other.

ALFUZOSIN HYDROCHLORIDE Extended-Release tablets are supplied as follows: Package NDC Number Bottles of 90 76282-302-90 Bottles of 100 76282-302-01 Bottles of 120 76282-302-12 Bottles of 500 76282-302-05 Bottles of 1000 76282-302-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Keep

ALFUZOSIN HYDROCHLORIDE out of reach of children.

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