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 063cfb19-5187-5b49-86e6-a441848f6c97
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
- 9dc40eda-2420-0a9b-cabe-172f38653fcb
- SPL ID
- 063cfb19-5187-5b49-86e6-a441848f6c97
- Version
- 1
- Effective date
- 2011-06-01
- Source export date
- 2026-10-22
- 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/2026-10-22/e902d457a1761a44fd3a30c39db9aa876f06b0835423db5444f8d1a30fdfcfa1/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
- Import run
- 20261023T001338Z
- Imported at
- 2026-10-23 01:35:50
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 | 063cfb19-5187-5b49-86e6-a441848f6c97 | id | |
| spl set id | 9dc40eda-2420-0a9b-cabe-172f38653fcb | 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.