FDA label 8f425ee7-663a-4f1d-a95c-ef18e48178ae

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
219ca5fb-fd4e-4145-9510-bc17c7860a51
SPL ID
8f425ee7-663a-4f1d-a95c-ef18e48178ae
Version
3
Effective date
2016-09-22
Source export date
2026-11-06
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/968b7138703f8100b14008bced2b2a4531f4fab250b207279e9c05eb19608f40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:16:17

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: Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use. Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

Reported adverse events (FAERS/openFDA)#

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