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 46ab2ed2-7798-415d-8b8b-64935e1a35f0
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
- b0a2fa3d-e511-49b7-af8b-ce4668c431f9
- SPL ID
- 46ab2ed2-7798-415d-8b8b-64935e1a35f0
- Version
- 1
- Effective date
- 2013-02-27
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:16:18
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 | 46ab2ed2-7798-415d-8b8b-64935e1a35f0 | id | |
| spl set id | b0a2fa3d-e511-49b7-af8b-ce4668c431f9 | 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.