FDA.reportPublic FDA data

FDA label 5d3e7048-01b0-4b8e-a2a6-250596d89cc2

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
62505de0-0bda-4184-9374-6a0301c3c2b7
SPL ID
5d3e7048-01b0-4b8e-a2a6-250596d89cc2
Version
2
Effective date
2020-09-14
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:32

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.