Hydroxyzine Hydrochloride 50 mg

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 preanesthetic 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.

caraco pharmaceutical laboratories, ltd.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] pain` `[3] rheumatoid arthritis` `[4] fatigue` `[5] off label use` `[6] arthralgia` `[7] condition aggravated` `[8] drug intolerance` `[9] rash` `[10] nausea`

2 years ago

ROUND WHITE 114

2 years ago

114 ROUND WHITE

HOW SUPPLIED HydrOXYzine hydrochloride tablets, USP contains 10 mg, 25 mg, or 50 mg of hydrOXYzine hydrochloride, USP and are supplied as follows: 10 mg: white to off-white, round, biconvex, bevel edge, film-coated tablets debossed with ‘112’ on one side and plain on the other side. NDC 57664-112-83 Bottles of 30 CRC NDC 57664-112-88 Bottles of 100 CRC NDC 57664-112-08 Bottles of 100 NCRC NDC 57664-112-13 Bottles of 500 NCRC NDC 57664-112-18 Bottles of 1000 NCRC 25 mg: white to off-white, round, biconvex, bevel edge, film-coated tablets debossed with‘113’ on one side and plain on the other side. NDC 57664-113-83 Bottles of 30 CRC NDC 57664-113-88 Bottles of 100 CRC NDC 57664-113-08 Bottles of 100 NCRC NDC 57664-113-13 Bottles of 500 NCRC NDC 57664-113-18 Bottles of 1000 NCRC 50 mg: white to off-white, round, biconvex, bevel edge, film-coated tablets debossed with ‘114’ on one side and plain on the other. NDC 57664-114-83 Bottles of 30 CRC NDC 57664-114-88 Bottles of 100 CRC NDC 57664-114-08 Bottles of 100 NCRC NDC 57664-114-13 Bottles of 500 NCRC NDC 57664-114-18 Bottles of 1000 NCRC Dispense in a tight container as defined in the USP. Store at 20 - 25°C (68 - 77°F). (See USP Controlled Room Temperature). Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries, Inc. Cranbury, New Jersey 08512 Issued: November 2008 Stock No. 6033T01

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