Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 10mg are available as white, round, biconvex film coated tablets, debossed "N5" on one side and plain on the other side, containing 10 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 11534-204-01), 500 (NDC 11534-204-04) and 1000 (NDC 11534-204-03) tablets. Hydroxyzine Hydrochloride Tablets USP, 25 mg ore available as white, round, biconvex film coated tablets, debossed "N6" on one side and plain on the other side, containing 25 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 11534-205-01), 500 (NDC 11534-205-04) and 1000 (NDC 11534-205-03) tablets. Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as white, round, biconvex film coated tablets, debossed "N7" on one side and plain on the other side, containing 50 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 11534-206-01), 500 (NDC 11534-206-04) and 1000 (NDC 11534-206-03) tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to77°F) [See USP Controlled Room temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 RO-101 Rev.01, 10/24; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Hydroxyzine Hydrochloride Tablets, USP 10 mg- 100 counts Hydroxyzine Hydrochloride Tablets, USP 10 mg- 500 counts Hydroxyzine Hydrochloride Tablets, USP 10 mg- 1000 counts Hydroxyzine Hydrochloride Tablets, USP 25 mg- 100 counts Hydroxyzine Hydrochloride Tablets, USP 25 mg- 500 counts Hydroxyzine Hydrochloride Tablets, USP 25 mg- 1000 counts Hydroxyzine Hydrochloride Tablets, USP 50 mg- 100 counts Hydroxyzine Hydrochloride Tablets, USP 50 mg- 500 counts Hydroxyzine Hydrochloride Tablets, USP 50 mg- 1000 counts hydroxyzinehcl-carton1 hydroxyzinehcl-carton2 hydroxyzinehcl-carton3 hydroxyzinehcl-carton4 hydroxyzinehcl-carton5 hydroxyzinehcl-carton6 hydroxyzinehcl-carton7 hydroxyzinehcl-carton8 hydroxyzinehcl-carton9
- HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 10mg are available as white, round, biconvex film coated tablets, debossed "N5" on one side and plain on the other side, containing 10 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 11534-204-01), 500 (NDC 11534-204-04) and 1000 (NDC 11534-204-03) tablets. Hydroxyzine Hydrochloride Tablets USP, 25 mg ore available as white, round, biconvex film coated tablets, debossed "N6" on one side and plain on the other side, containing 25 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 11534-205-01), 500 (NDC 11534-205-04) and 1000 (NDC 11534-205-03) tablets. Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as white, round, biconvex film coated tablets, debossed "N7" on one side and plain on the other side, containing 50 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 11534-206-01), 500 (NDC 11534-206-04) and 1000 (NDC 11534-206-03) tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to77°F) [See USP Controlled Room temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 RO-101 Rev.01, 10/24
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Hydroxyzine Hydrochloride Tablets, USP 10 mg- 100 counts Hydroxyzine Hydrochloride Tablets, USP 10 mg- 500 counts Hydroxyzine Hydrochloride Tablets, USP 10 mg- 1000 counts Hydroxyzine Hydrochloride Tablets, USP 25 mg- 100 counts Hydroxyzine Hydrochloride Tablets, USP 25 mg- 500 counts Hydroxyzine Hydrochloride Tablets, USP 25 mg- 1000 counts Hydroxyzine Hydrochloride Tablets, USP 50 mg- 100 counts Hydroxyzine Hydrochloride Tablets, USP 50 mg- 500 counts Hydroxyzine Hydrochloride Tablets, USP 50 mg- 1000 counts hydroxyzinehcl-carton1 hydroxyzinehcl-carton2 hydroxyzinehcl-carton3 hydroxyzinehcl-carton4 hydroxyzinehcl-carton5 hydroxyzinehcl-carton6 hydroxyzinehcl-carton7 hydroxyzinehcl-carton8 hydroxyzinehcl-carton9
Overview
Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 CIN 2 O 2 . 2HCl M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. lnactive ingredients include: carnauba wax, colloidal sllicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. hydroxyzinehcl-structure
Indications & 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.
Dosage & Administration
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 mg to 100 mg four times daily (q.i.d.); children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 mg to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg three times daily (t.i.d.) or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 mg to100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 mg to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.
Warnings & Precautions
WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
Contraindications
Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.
Adverse Reactions
Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic : Dry mouth. Central Nervous System : Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. lnvoluntory motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System : QT prolongation, Torsade de Pointes. ln postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole : Allergic reaction. Nervous System : Headache. Psychiatric : Hallucination. Skin and Appendages : Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports; pruritus, rash, urticaria.
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