Hydroxyzine Hydrochloride (Page 2 of 2)

OVERDOSAGE

The most common manifestation of hydroxyzine overdosage is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

DOSAGE AND 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.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets, USP are available as follows:

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 10: NDC 70934-981-10

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 25 MG(100 TABLETS)

NDC: 70934-981-10

HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-981(NDC:23155-501) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROXYZINE DIHYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE CROSPOVIDONE

Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code H;501 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70934-981-10 10 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204279 06/16/2022

Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Establishment
Name	Address	ID/FEI	Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals		080355546	repack (70934-981)

Revised: 06/2022 Denton Pharma, Inc. DBA Northwind Pharmaceuticals