labetalol hcl tablet film coated
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.
Eon Labs, Inc.
ROUND WHITE E 117
E 117 ROUND WHITE
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labetalol hcl tablet film coated
eon labs, inc.
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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: NDC 0185-0010-01 bottles of 100 NDC 0185-0010-05 bottles of 500 NDC 0185-0010-10 bottles of 1000 200 mg round, white, film-coated tablets, debossed “ E” over “ 117” on one side and bisected on the other side and supplied as: NDC 0185-0117-01 bottles of 100 NDC 0185-0117-05 bottles of 500 NDC 0185-0117-10 bottles of 1000 300 mg round, white, film-coated tablets, debossed “ E” over “ 118” on one side and plain on the other side and supplied as: NDC 0185-0118-01 bottles of 100 NDC 0185-0118-05 bottles of 500 NDC 0185-0118-10 bottles of 1000 Labetalol Hydrochloride Tablets, USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. 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. Manufactured by Sandoz Inc. Princeton, NJ 08540 Rev. October 2016 MF0010REV10/16 46192934
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