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
- 2026-11-06
- 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/2026-11-06/5ab46f90f6b44e2aa9affb3cb9a1420d82b92a8f942c23fe463364760a659d66/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 08:10:16
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.