warnings
WARNINGS Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
FDA label d60fd320-eb36-4489-e053-2995a90a8432
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
- SPL set ID
- afd7b4c9-9ef0-52e8-e053-2a95a90a6b33
- SPL ID
- d60fd320-eb36-4489-e053-2995a90a8432
- Version
- 3
- Effective date
- 2022-01-20
- 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 06:34:55
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 |
|---|---|---|---|
| spl id | d60fd320-eb36-4489-e053-2995a90a8432 | id | |
| spl set id | afd7b4c9-9ef0-52e8-e053-2a95a90a6b33 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.