FDA label e4f3161b-38fd-456d-9ff3-20d92e828c50

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
3244852e-61f3-4676-80ed-3f76b6941dc1
SPL ID
e4f3161b-38fd-456d-9ff3-20d92e828c50
Version
4
Effective date
2018-02-14
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:37

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 you have ever had an allergic reaction to this product or any of its ingredients. ​Ask a doctor before use if ​ excessive redness or swelling is present. ​Stop use and ask a doctor if ​ symptoms persist, worsen or if new symptoms occur. ​Keep out of reach of children. ​ In case of overdose, get medical help or call a Poison Control Center right away. ​If pregnant or breast feeding, ​ ask a doctor before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Reported adverse events (FAERS/openFDA)#

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