FDA label 4394946f-7688-c546-e063-6294a90a12ab
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
- be05bed1-4531-4db6-9d68-f9cdf1f6cd6f
- SPL ID
- 4394946f-7688-c546-e063-6294a90a12ab
- Version
- 3
- Effective date
- 2025-11-14
- Source export date
- 2026-10-12
- 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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:18:19
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 | 4394946f-7688-c546-e063-6294a90a12ab | id | |
| spl set id | be05bed1-4531-4db6-9d68-f9cdf1f6cd6f | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings For external use only. If taken internally serious gastric disturbances will result.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse reaction Manufactured for Big Lots By: Vi-Jon, LLC 8515 Page Avenue, St Louis, MO 63114 Pat. D675, 101
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.