Label: HYDROXYZINE HYDROCHLORIDE solution

  • NDC Code(s): 0121-1034-16
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 13, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Hydroxyzine hydrochloride is designated chemically as ( ±)2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows:  Inactive ...
  • CLINICAL PHARMACOLOGY
    Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine is not a cortical depressant, but its action may be due to a ...
  • INDICATIONS AND 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 ...
  • CONTRAINDICATIONS
    Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine ...
  • WARNINGS
    Keep out of the reach of children. 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 ...
  • PRECAUTIONS
    THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS, AND BARBITURATES ...
  • ADVERSE REACTIONS
    Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Call your doctor for medical advice about side effects. To report SUSPECTED ...
  • OVERDOSAGE
    The most common manifestation of hydroxyzine overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If ...
  • 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, 50–100 mg q.i.d.; children under ...
  • HOW SUPPLIED
    Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) 10 mg per 5 mL (teaspoonful) is a clear, colorless to slightly yellow solution supplied as: 16 fl oz bottles (473 mL) [NDC 0121-1034-16]
  • 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 tight, light-resistant container as defined in the USP, with ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0121-1034-16 - HydrOXYzine - Hydrochloride - Oral Solution, USP - (Syrup) 10 mg/5 mL - Alcohol .... 0.5% (v/v) DO NOT USE IF INNER FOIL SEAL - IS BROKEN OR MISSING.  This container not ...
  • INGREDIENTS AND APPEARANCE
    Product Information