labetalol hydrochloride 200 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.

advagen pharma ltd

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

3 years ago

ROUND WHITE R 20

3 years ago

R 20 ROUND WHITE

HOW SUPPLIED

LABETALOL HYDROCHLORIDE Tablets USP, for oral administration, are available as: 100 mg white, circular, biconvex, film coated tablets debossed with '21' on one side and score-line and 'R' on other side of the tablet. NDC 72888-120-01 bottles of 100 NDC 72888-120-05 bottles of 500 200 mg white, circular, biconvex, film coated tablets debossed with '20' on one side and score-line and 'R' on other side of the tablet. NDC 72888-121-01 bottles of 100 NDC 72888-121-05 bottles of 500 300 mg white, circular, biconvex, film coated tablets debossed with '22' on one side and 'R' on other side of the tablet. NDC 72888-122-01 bottles of 100 NDC 72888-122-05 bottles of 500

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 Advagen Pharma Ltd at +1-609-269 8128 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed By: Advagen Pharma Ltd, Suite 605, Princeton Office Center II, 666 plainsboro Road plainsboro, New Jersey, 08536. United States. Manufactured By: Rubicon Research PVT Ltd, Ambernath, Dist.Thane, 421506 India. Rev. 01, November 2018

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