Hydroxyzine Hydrochloride 50 MG Oral Tablet

INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Major Pharmaceuticals

FDA Reported Adverse Reactions
`[1] neutropenia` `[2] drug ineffective` `[3] adverse drug reaction` `[4] hospitalisation` `[5] toxicity to various agents` `[6] death` `[7] completed suicide` `[8] drug abuse` `[9] off label use` `[10] drug interaction`

5 years ago

ROUND WHITE K12

HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available as follows: Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed "K10" on one side and plain on the other side. Bottles of 100 tablets, NDC 0904-0357-60 Bottles of 500 tablets, NDC 0904-0357-40 Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed "K11" on one side and plain on the other side. Bottles of 100 tablets, NDC 0904-0358-60 Bottles of 500 tablets, NDC 0904-0358-40 Bottles of 1000 tablets, NDC 0904-0358-80 Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed "K12" on one side and plain on the other side. Bottles of 100 tablets, NDC 0904-0359-60 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Item ID # 6015/12 11/2018 Manufacturer’s Code: 10702 company logo

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