warnings
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 mothers.
Hydroxyzine Hydrochloride
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Hydroxyzine Hydrochloride
- Generic name
- HYDROXYZINE HYDROCHLORIDE ORAL
- Manufacturer
- Bionpharma Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 39f93633-000e-6c3f-e063-6394a90a5a0b
- SPL ID
- 39f93640-6535-6c3b-e063-6394a90a7f2d
- Version
- 1
- Effective date
- 2025-07-15
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:37:37
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 219289 | derived:openfda.application_number |
| application number | ANDA219289 | openfda.application_number | |
| brand name | Hydroxyzine Hydrochloride | openfda.brand_name | |
| generic name | HYDROXYZINE HYDROCHLORIDE ORAL | openfda.generic_name | |
| manufacturer name | Bionpharma Inc. | openfda.manufacturer_name | |
| ndc | package | 69452-395-88 | openfda.package_ndc |
| ndc | product | 69452-395 | openfda.product_ndc |
| ndc11 | package | 69452039588 | derived:openfda.package_ndc |
| rxcui | 995241 | openfda.rxcui | |
| spl id | 39f93640-6535-6c3b-e063-6394a90a7f2d | id | |
| spl set id | 39f93633-000e-6c3f-e063-6394a90a5a0b | set_id | |
| unii | 76755771U3 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Skin and appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP), fixed drug eruptions, pruritis, rash and urticaria in post marketing reports. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.