Hydroxyzine Hydrochloride 25 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.
HARRIS Pharmaceutical, Inc.
ROUND WHITE AN 71
AN 71 ROUND WHITE
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HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are white, round, film coated, biconvex tablets containing 10 mg, 25 mg, or 50 mg of Hydroxyzine Hydrochloride, and supplied as: 10 mg Tablets: debossed '75' on one side and 'A' on the other NDC 67405-575-10 Bottles of 100 NDC 67405-575-50 Bottles of 500 NDC 67405-575-96 Bottles of 1000 25 mg Tablets: debossed '71' on one side and 'AN' on the other NDC 67405-671-10 Bottles of 100 NDC 67405-671-50 Bottles of 500 NDC 67405-671-96 Bottles of 1000 50 mg Tablets: debossed '77' on one side and 'AN' on the other NDC 67405-577-10 Bottles of 100 NDC 67405-577-50 Bottles of 500 NDC 67405-577-96 Bottles of 1000 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP. Manufactured for: HARRIS Pharmaceutical, Inc. Fort Myers, FL 33908 877-RX4-DERM • www.HarrisPharmaceutical.com Manufactured by: Amneal Pharmaceuticals Paterson, NJ 07504 Rev: 10-2016-03 177e24c2-figure-02
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