warnings
WARNINGS Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
FDA label 9a2d773a-3076-84c5-e053-2995a90a5864
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
- c6a339dc-d56a-49d9-bf74-af54d2ba9b3c
- SPL ID
- 9a2d773a-3076-84c5-e053-2995a90a5864
- Version
- 4
- Effective date
- 2019-12-20
- Source export date
- 2026-10-30
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:57:37
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 | 9a2d773a-3076-84c5-e053-2995a90a5864 | id | |
| spl set id | c6a339dc-d56a-49d9-bf74-af54d2ba9b3c | 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.