Labetalol hydrochloride 100 MG Oral Tablet
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
ROUND WHITE E 10
E 10 ROUND WHITE
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HOW SUPPLIED Labetalol Hydrochloride Tablets, USP, for oral administration, are available as 100 mg round, white, film-coated tablets, debossed “ E” over “ 10” on one side and bisected on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-114-01 200 mg round, white, film-coated tablets, debossed “ E” over “ 117” on one side and bisected on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-125-01 300 mg round, white, film-coated tablets, debossed “ E” over “ 118” on one side and plain on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-136-01 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from bluePoint Laboratories as follows: (100 mg / 100 UD) NDC 60687-114-01 packaged from NDC 68001-205 (200 mg / 100 UD) NDC 60687-125-01 packaged from NDC 68001-204 (300 mg / 100 UD) NDC 60687-136-01 packaged from NDC 68001-206 Distributed by: American Health Packaging Columbus, OH 43217 8411401/0117OS
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