FDA label 5fadf1e2-d1cf-6cce-e053-2991aa0aec4b

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
d0978b31-cdc9-46a5-9e29-5ea91031e4ca
SPL ID
5fadf1e2-d1cf-6cce-e053-2991aa0aec4b
Version
3
Effective date
2017-12-06
Source export date
2026-08-17
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/2026-08-17/559e90e291f706011ac4a15e81427bf26ca36e5d0b9d84e84d297d7c5834404b/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:01:08

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.