FDA.reportPublic FDA data

FDA label abc664bc-f816-4be9-8bce-e1f2ee502407

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
b0b3f916-c915-423b-9daa-70b99a6d3ea9
SPL ID
abc664bc-f816-4be9-8bce-e1f2ee502407
Version
1
Effective date
2013-04-03
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:24

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

Warnings Do not use if hypersensitive to poison sumac. When using this product in very rare cases, gastrointestinal complaints may occur after use. In this case discontinue use of product. in very rare cases, skin reactions may occur after use. In this case discontinue use of product. Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur. If pregnant or breastfeeding , ask a health care professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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