labetalol 300 mg

INDICATIONS AND USAGE Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

american health packaging

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

6 months ago

ROUND GREEN 800

HOW SUPPLIED

LABETALOL HYDROCHLORIDE Tablets, USP for oral administration are available as:

LABETALOL HYDROCHLORIDE Tablets USP, 100 mg are yellow colored, round, biconvex, film-coated tablets debossed with "7" and "98" on either side of score line on one side and plain on other side and are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-439-01

LABETALOL HYDROCHLORIDE Tablets USP, 200 mg are white to off white colored, round, biconvex, film-coated tablets debossed with "7" and "99" on either side of score line on one side and plain on other side and are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-450-01

LABETALOL HYDROCHLORIDE Tablets USP, 300 mg are light green colored, round, biconvex, beveled edge, film-coated tablets debossed with "800" on one side and plain on other side and are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-461-01

LABETALOL HYDROCHLORIDE Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . This product's package insert may have been updated. For current package insert, call American Health Packaging at 1-800-707-4621. PACKAGING INFORMATION American Health Packaging unit dose blisters (see HOW SUPPLIED section) contain drug product from bluePoint Laboratories as follows: (100 mg / 100UD) NDC 60687-439-01 packaged from NDC 68001-381 (200 mg / 100UD) NDC 60687-450-01 packaged from NDC 68001-382 (300 mg / 100UD) NDC 60687-461-01 packaged from NDC 68001-383 Distributed by: American Health Packaging Columbus, OH 43217 8443901/0823

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