FDA label 5faddf54-ffde-d97d-e053-2991aa0a02b0

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID
6b179346-de7b-49c0-8cc0-48f5c0a26ac9
SPL ID
5faddf54-ffde-d97d-e053-2991aa0a02b0
Version
6
Effective date
2017-12-06
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:27

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

• WARNINGS AND PRECAUTIONS Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

• ADVERSE EVENTS To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.