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
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SPL UNCLASSIFIED SECTIONRx only
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DESCRIPTIONHydroxyzine hydrochloride is designated chemically as ( ±)2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows: Inactive ...
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CLINICAL PHARMACOLOGYHydroxyzine 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 ...
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INDICATIONS AND USAGEFor 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 ...
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CONTRAINDICATIONSOral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine ...
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WARNINGSKeep 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 ...
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PRECAUTIONSTHE 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 ...
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ADVERSE REACTIONSSide 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 ...
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OVERDOSAGEThe 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 ...
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DOSAGE AND ADMINISTRATIONFor 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 ...
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HOW SUPPLIEDHydroxyzine 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]
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RECOMMENDED STORAGEStore 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 ...
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PRINCIPAL DISPLAY PANELNDC 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 ...
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INGREDIENTS AND APPEARANCEProduct Information