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 four times daily.: 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: in adults, 25 mg three times to four times daily.; 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 Syrup (Hydroxyzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL (teaspoonful) is a slightly yellow peppermint flavored liquid, supplied in 473 mL (16 fl. oz.) amber plastic bottles.

NDC 62135-502-47

Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP controlled room temperature].

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


Manufactured for:

Chartwell RX, LLC.

Congers, NY 10920


L71089

Rev. 10/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydroxyzine Hydrochloride Syrup, 10mg/5mL — NDC-62135-502-47 — 437mL — Bottle Label

image description
(click image for full-size original)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-502
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE DIHYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SODIUM BENZOATE
SUCROSE
WATER
SODIUM CITRATE
Product Characteristics
Color yellow (slightly yellow) Score
Shape Size
Flavor PEPPERMINT (peppermint flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-502-47 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201674 08/21/2013
Labeler — Chartwell RX, LLC (079394054)
Registrant — Chartwell Pharmaceticals Carmel, LLC (118673485)
Establishment
Name Address ID/FEI Operations
Chartwell Pharmaceticals Carmel, LLC 118673485 analysis (62135-502), label (62135-502), manufacture (62135-502), pack (62135-502)

Revised: 10/2022 Chartwell RX, LLC

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