Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available as follows: Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed "K10" on one side and plain on the other side. Bottle of 100, NDC 10702-010-01 Bottle of 500, NDC 10702-010-50 Bottle of 1000, NDC 10702-010-10 Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed "K11" on one side and plain on the other side. Bottle of 100, NDC 10702-011-01 Bottle of 500, NDC 10702-011-50 Bottle of 1000, NDC 10702-011-10 Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed "K12" on one side and plain on the other side. Bottle of 100, NDC 10702-012-01 Bottle of 500, NDC 10702-012-50 Bottle of 1000, NDC 10702-012-10 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940 Item ID # 6015/12 11/2018 Manufacturer’s Code: 10702 company logo; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 10 mg Bottle Label Packaging Size: 100s NDC 10702-010-01 HydrOXYzine HCL Tablets, USP 10 mg 100 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 500s NDC 10702-010-50 HydrOXYzine HCL Tablets, USP 10 mg 500 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 1000s NDC 10702-010-10 HydrOXYzine HCL Tablets, USP 10 mg 1000 TABLETS Rx Only KVK-TECH, INC. label 10 mg - 100s label 10 mg - 500s label 10 mg - 1000s; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 25 mg Bottle Label Packaging Size: 100s NDC 10702-011-01 HydrOXYzine HCL Tablets, USP 25 mg 100 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 500s NDC 10702-011-50 HydrOXYzine HCL Tablets, USP 25 mg Rx Only 500 TABLETS KVK-TECH, INC. Packaging Size: 1000s NDC 10702-011-01 HydrOXYzine HCL Tablets, USP 25 mg 1000 TABLETS Rx Only KVK-TECH, INC. label 25 mg - 100s label 25 mg - 500s label 25 mg - 1000s; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 50 mg Bottle Label Packaging Size: 100s NDC 10702-012-01 HydrOXYzine HCL Tablets, USP 50 mg 100 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 500s NDC 10702-012-50 HydrOXYzine HCL Tablets, USP 50 mg 500 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 1000s NDC 10702-012-10 HydrOXYzine HCL Tablets, USP 50 mg 1000 TABLETS Rx Only KVK-TECH, INC. Label 50 mg - 100s Label 50 mg - 500s Label 50 mg - 1000s
- HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available as follows: Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed "K10" on one side and plain on the other side. Bottle of 100, NDC 10702-010-01 Bottle of 500, NDC 10702-010-50 Bottle of 1000, NDC 10702-010-10 Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed "K11" on one side and plain on the other side. Bottle of 100, NDC 10702-011-01 Bottle of 500, NDC 10702-011-50 Bottle of 1000, NDC 10702-011-10 Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed "K12" on one side and plain on the other side. Bottle of 100, NDC 10702-012-01 Bottle of 500, NDC 10702-012-50 Bottle of 1000, NDC 10702-012-10 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940 Item ID # 6015/12 11/2018 Manufacturer’s Code: 10702 company logo
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 10 mg Bottle Label Packaging Size: 100s NDC 10702-010-01 HydrOXYzine HCL Tablets, USP 10 mg 100 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 500s NDC 10702-010-50 HydrOXYzine HCL Tablets, USP 10 mg 500 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 1000s NDC 10702-010-10 HydrOXYzine HCL Tablets, USP 10 mg 1000 TABLETS Rx Only KVK-TECH, INC. label 10 mg - 100s label 10 mg - 500s label 10 mg - 1000s
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 25 mg Bottle Label Packaging Size: 100s NDC 10702-011-01 HydrOXYzine HCL Tablets, USP 25 mg 100 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 500s NDC 10702-011-50 HydrOXYzine HCL Tablets, USP 25 mg Rx Only 500 TABLETS KVK-TECH, INC. Packaging Size: 1000s NDC 10702-011-01 HydrOXYzine HCL Tablets, USP 25 mg 1000 TABLETS Rx Only KVK-TECH, INC. label 25 mg - 100s label 25 mg - 500s label 25 mg - 1000s
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 50 mg Bottle Label Packaging Size: 100s NDC 10702-012-01 HydrOXYzine HCL Tablets, USP 50 mg 100 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 500s NDC 10702-012-50 HydrOXYzine HCL Tablets, USP 50 mg 500 TABLETS Rx Only KVK-TECH, INC. Packaging Size: 1000s NDC 10702-012-10 HydrOXYzine HCL Tablets, USP 50 mg 1000 TABLETS Rx Only KVK-TECH, INC. Label 50 mg - 100s Label 50 mg - 500s Label 50 mg - 1000s
Overview
Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p -Chloro- α -phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. Hydroxyzine hydrochloride 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. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol and titanium dioxide. This product complies with USP dissolution test 2. chemical 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 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 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 t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 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 it.
Adverse Reactions
Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. 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. Involuntary 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. In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole : Allergic reaction. Nervous System : Headache. Psychiatric : Hallucination. Skin and Appendages : Pruritus, rash, urticaria.
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