warnings and cautions
Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for children under 18 months of age Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF Do not use if seal is broken
FDA label b60e1d59-0d3d-137c-e053-2a95a90a7c2a
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
- 3b56f852-1eb9-4451-be74-0e5f2ef49983
- SPL ID
- b60e1d59-0d3d-137c-e053-2a95a90a7c2a
- Version
- 6
- Effective date
- 2020-12-09
- Source export date
- 2026-09-28
- 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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:01:29
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 | b60e1d59-0d3d-137c-e053-2a95a90a7c2a | id | |
| spl set id | 3b56f852-1eb9-4451-be74-0e5f2ef49983 | 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.