Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 10 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “307” on the other side, containing 10 mg hydroxyzine hydrochloride, USP packaged: Unit dose packages of 100 (10 x 10) NDC 60687-664-01 Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “308” on the other side, containing 25 mg hydroxyzine hydrochloride, USP packaged in: Unit dose packages of 100 (10 x 10) NDC 60687-675-01 Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “309” on the other side, containing 50 mg hydroxyzine hydrochloride, USP packaged in: Unit dose packages of 100 (10 x 10) NDC 60687-686-01 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. FOR YOUR PROTECTION: Do not use if blister is torn or broken.; Package/Label Display Panel – Carton – 10 mg NDC 60687- 664 -01 HydrOXYzine Hydrochloride Tablets USP 10 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydroxyzine hydrochloride, USP .............................................10 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0093-5060, TEVA PHARMACEUTICALS USA, INC. Distributed by: American Health Packaging, Columbus, Ohio 43217 766401 0466401/0924 10 mg Hydroxyzine Tablets Carton; Package/Label Display Panel – Blister – 10 mg HydrOXYzine Hydrochloride Tablet USP 10 mg 10 mg HydrOXYzine Hydrochloride Tablet Blister; Package/Label Display Panel – Carton – 25 mg NDC 60687- 675 -01 HydrOXYzine Hydrochloride Tablets USP 25 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydroxyzine hydrochloride, USP ............................................. 25 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0093-5061, TEVA PHARMACEUTICALS USA, INC. Distributed by: American Health Packaging, Columbus, Ohio 43217 767501 0467501/0924 25 mg Hydroxyzine Tablets Carton; Package/Label Display Panel – Blister – 25 mg HydrOXYzine Hydrochloride Tablet USP 25 mg 25 mg HydrOXYzine Hydrochloride Tablet Blister; Package/Label Display Panel – Carton – 50 mg NDC 60687- 686 -01 HydrOXYzine Hydrochloride Tablets USP 50 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydroxyzine hydrochloride, USP ............................................. 50 mg Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep this and all drugs out of reach of children. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0093-5062, TEVA PHARMACEUTICALS USA, INC. Distributed by: American Health Packaging Columbus, Ohio 43217 768601 0468601/0222 50 mg HydrOXYzine Hydrochloride Tablets Carton; Package/Label Display Panel – Blister – 50 mg HydrOXYzine Hydrochloride Tablet USP 50 mg 50 mg HydrOXYzine Hydrochloride Tablet Blister
- HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 10 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “307” on the other side, containing 10 mg hydroxyzine hydrochloride, USP packaged: Unit dose packages of 100 (10 x 10) NDC 60687-664-01 Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “308” on the other side, containing 25 mg hydroxyzine hydrochloride, USP packaged in: Unit dose packages of 100 (10 x 10) NDC 60687-675-01 Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “309” on the other side, containing 50 mg hydroxyzine hydrochloride, USP packaged in: Unit dose packages of 100 (10 x 10) NDC 60687-686-01 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. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
- Package/Label Display Panel – Carton – 10 mg NDC 60687- 664 -01 HydrOXYzine Hydrochloride Tablets USP 10 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydroxyzine hydrochloride, USP .............................................10 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0093-5060, TEVA PHARMACEUTICALS USA, INC. Distributed by: American Health Packaging, Columbus, Ohio 43217 766401 0466401/0924 10 mg Hydroxyzine Tablets Carton
- Package/Label Display Panel – Blister – 10 mg HydrOXYzine Hydrochloride Tablet USP 10 mg 10 mg HydrOXYzine Hydrochloride Tablet Blister
- Package/Label Display Panel – Carton – 25 mg NDC 60687- 675 -01 HydrOXYzine Hydrochloride Tablets USP 25 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydroxyzine hydrochloride, USP ............................................. 25 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0093-5061, TEVA PHARMACEUTICALS USA, INC. Distributed by: American Health Packaging, Columbus, Ohio 43217 767501 0467501/0924 25 mg Hydroxyzine Tablets Carton
- Package/Label Display Panel – Blister – 25 mg HydrOXYzine Hydrochloride Tablet USP 25 mg 25 mg HydrOXYzine Hydrochloride Tablet Blister
- Package/Label Display Panel – Carton – 50 mg NDC 60687- 686 -01 HydrOXYzine Hydrochloride Tablets USP 50 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydroxyzine hydrochloride, USP ............................................. 50 mg Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep this and all drugs out of reach of children. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0093-5062, TEVA PHARMACEUTICALS USA, INC. Distributed by: American Health Packaging Columbus, Ohio 43217 768601 0468601/0222 50 mg HydrOXYzine Hydrochloride Tablets Carton
- Package/Label Display Panel – Blister – 50 mg HydrOXYzine Hydrochloride Tablet USP 50 mg 50 mg HydrOXYzine Hydrochloride Tablet Blister
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 ClN 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. Inactive ingredients include: anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin. Structural Formula
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 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. 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: Oral hydroxyzine is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports; pruritus, rash, urticaria.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.