warnings
WARNINGS: Do Not Use if tamper evident seal is missing or broken. Pregnancy or Breast Feeding As with any drug, it you are pregnant or nursing, consult a health care professional before using this product. Keep out of the reach of children.
FDA label 0b528b3e-5cd1-e56c-e063-6394a90a3e7d
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
- 6b613a6f-64cc-4cda-88c4-27e839cc5e43
- SPL ID
- 0b528b3e-5cd1-e56c-e063-6394a90a3e7d
- Version
- 2
- Effective date
- 2023-11-29
- Source export date
- 2026-11-06
- 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/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 08:09:04
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 | 0b528b3e-5cd1-e56c-e063-6394a90a3e7d | id | |
| spl set id | 6b613a6f-64cc-4cda-88c4-27e839cc5e43 | 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.