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
ROUND WHITE K12
K12 ROUND WHITE
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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 sid in bottles of 100. NDC 0904-0357-60.
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 in bottles of 100, NDC 0904-0358-60. Bottles of 1000, 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 in bottles of 100. NDC 0904-0359-60. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20o to 25oC with excursions permitted between 15o to 30oC (59o to 86oF) [See USP Controlled Room Temperature].
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