labetalol hydrochloride 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.

zydus pharmaceuticals (usa) inc.

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

6 years ago

ROUND WHITE 7 99

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: NDC 68382-798-06 in bottle of 30 tablets NDC 68382-798-16 in bottle of 90 tablets NDC 68382-798-01 in bottle of 100 tablets NDC 68382-798-05 in bottle of 500 tablets

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: NDC 68382-799-06 in bottle of 30 tablets NDC 68382-799-16 in bottle of 90 tablets NDC 68382-799-01 in bottle of 100 tablets NDC 68382-799-05 in bottle of 500 tablets

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: NDC 68382-800-06 in bottle of 30 tablets NDC 68382-800-16 in bottle of 90 tablets NDC 68382-800-01 in bottle of 100 tablets NDC 68382-800-05 in bottle of 500 tablets

LABETALOL HYDROCHLORIDE Tablets USP should be Stored at 20°C to 25°C (68°F 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 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, please visit www.zydususa.com Manufactured by: Zydus Lifesciences Ltd. Matoda, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 08/22

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