FDA.reportPublic FDA data

FDA label b8689d00-25c5-535d-e053-2a95a90a30ae

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
b8691c99-eb91-3305-e053-2995a90a9488
SPL ID
b8689d00-25c5-535d-e053-2a95a90a30ae
Version
1
Effective date
2021-01-08
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:06:27

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: Side effects might include headache, nausea, sore throat, allergic rhinitis, gastrointestinal discomfort, itchiness or mild rash. If symptoms persist or worsen, stop using this product and consult a physician. Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention. If pregnant or breastfeeding, ask a health professional before use. If diagnosed with psychiatric or mood disorder, seek medical advice before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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