Hydroxyzine Hydrochloride 25 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 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.

heritage pharmaceuticals inc.

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

6 years ago

ROUND WHITE H 501

6 years ago

H 501 ROUND WHITE

HOW SUPPLIED

HYDROXYZINE HYDROCHLORIDE Tablets, USP are available as follows: 10 mg tablets: round, film coated white tablets. debossed H on one side and 500 on the reverse side. They are available as follows: Bottles of 100: NDC 23155-500-01 Bottles of 500: NDC 23155-500-05 Bottles of 1000: NDC 23155-500-10 25 mg tablets: round, film coated white tablets. debossed H over 501 on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 23155-501-01 Bottles of 500: NDC 23155-501-05 Bottles of 1000: NDC 23155-501-10 50 mg tablets: round, film coated white tablets. debossed H over 502 on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 23155-502-01 Bottles of 500: NDC 23155-502-05 Bottles of 1000: NDC 23155-502-10 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. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000193US08 Rev. 09/2021 OR Manufactured by: Emcure Pharmaceuticals Ltd., Kadu, Surendranagar - 382775, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 510490427US01 Revised: 06/2023 logo

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heritage pharmaceuticals inc.

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