warnings
- GI system: may cause nausea, vomiting, diarrhea, or abdominal discomfort - dizziness (one case), headache (one case), and constipation (three cases) were reported during clinical trials
FDA label 9b035360-3432-44e8-9e2b-ff955422c493
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
- a188dc5f-7c15-43dd-9bef-6565b93bf63d
- SPL ID
- 9b035360-3432-44e8-9e2b-ff955422c493
- Version
- 1
- Effective date
- 2013-02-27
- Source export date
- 2026-11-06
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:29:22
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 | 9b035360-3432-44e8-9e2b-ff955422c493 | id | |
| spl set id | a188dc5f-7c15-43dd-9bef-6565b93bf63d | 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.