warnings
WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children
FDA label 84365aa1-1068-c019-b6cb-e2688e8b2594
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
- df2ca7f9-dd86-e90d-5ff2-44b1c1e8ba81
- SPL ID
- 84365aa1-1068-c019-b6cb-e2688e8b2594
- Version
- 1
- Effective date
- 2011-03-01
- Source export date
- 2026-11-06
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/423686b2ac39507df6931677ae004637f2f017f82cbe44b047a75ba358b9d453/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 08:54:49
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 | 84365aa1-1068-c019-b6cb-e2688e8b2594 | id | |
| spl set id | df2ca7f9-dd86-e90d-5ff2-44b1c1e8ba81 | 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.