hydroxyzine hydrochloride 25 MG hydroxyzine pamoate 42.6 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.

Northstar RxLLC

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

3 months ago

ROUND WHITE N004

3 months ago

N004 ROUND WHITE

HOW SUPPLIED

HYDROXYZINE HYDROCHLORIDE Tablets, USP are supplied as: 10 mg - white, biconvex, circular, coated tablets with '112' debossed on one face and 'N' on the other face. Bottles of 100 tablets NDC 16714-081-10 Bottles of 500 tablets NDC 16714-081-11 25 mg- white, biconvex, circular, coated tablets with 'N004' debossed on one face and plain on the other face. Bottles of 100 tablets NDC 16714-082-10 Bottles of 500 tablets NDC 16714-082-11 Bottles of 1000 tablets NDC 16714-082-12 50 mg- white, biconvex, circular, coated tablets with 'N006' debossed on one face and plain on the other face. Bottles of 100 tablets NDC 16714-083-10 Bottles of 500 tablets NDC 16714-083-11 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free Number: 1-800-206-7821 Manufactured by: Piramal Pharma Limited, Plot No. 67-70, Sector-2, Pithampur 454 775, Dist.: Dhar, Madhya Pradesh, INDIA. October 2020

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