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
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:57

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: 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.