HYDROXYZINE HYDROCHLORIDE (Page 2 of 2)

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: in adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and 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: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and 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 in adults, and 0.6 mg/kg in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

HOW SUPPLIED

Hydroxyzine Hydrochloride Oral Solution, USP 10 mg per 5 mL (teaspoonful) is a slightly yellow peppermint flavored liquid, supplied in Pint (473 mL) plastic bottles.

NDC #13668-582-10

RECOMMENDED STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

PROTECT FROM FREEZING.

PROTECT FROM LIGHT.

Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

Rx Only

​Manufactured by:

Bio-Pharm, Inc.

Levittown, PA 19057

Manufactured for:

TORRENT PHARMAC INC.

Basking Ridge, NJ 07920

company-logo

Made in USA

Revised 05/2018

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL — 10 mg per 5 mL

hydrOXYzine Hydrochloride Oral Solution, USP

10 mg per 5 mL

ALCOHOL FREE

Do not use if the inner foil seal is broken or missing

BULK CONTAINER — This container is not intended for household use.

Rx only

Net: 1 Pint (473 mL)

hydroxyzine-hcl-10mg-5ml-473ml
(click image for full-size original)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-582
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
PEPPERMINT
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SUCROSE
WATER
Product Characteristics
Color yellow (slightly yellow) Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-582-10 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210634 02/26/2019
Labeler — Torrent Pharmaceuticals Limited (916488547)

Revised: 03/2019 Torrent Pharmaceuticals Limited

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