FDA.reportPublic FDA data

FDA label 4cefb645-9980-44f7-8e11-794448d38366

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
06616a68-5a01-4a8f-9269-6c28825cf0a7
SPL ID
4cefb645-9980-44f7-8e11-794448d38366
Version
1
Effective date
2011-07-05
Source export date
2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:57

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 pregnant or nursing. If allergic to nickel or costume jewelry, use only under the advice and supervision of a physician. If symptoms worsen, contact a physician. Keep out of reach of children. CAUTION: Use only as directed . Do not give to children under ten years old or use in the presence of kidney disease. If skin rash appears or if nervous symptoms persist, recur frequently or are unusual, discontinue use and consult a physician.

Reported adverse events (FAERS/openFDA)#

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