FDA.reportPublic FDA data

FDA label eda9f5bc-1a20-4591-b1c1-3b015952c8db

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
f4ca87b4-e222-4c90-9423-c84b6a5668ad
SPL ID
eda9f5bc-1a20-4591-b1c1-3b015952c8db
Version
1
Effective date
2011-06-29
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:51

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: If symptoms persist or worsen, contact a physician. If pregnant or nursing, use only under the advice and supervision of a physician. Keep our of the reach of children. Safety Sealed for your protection. Do not use if imprinted seal around bottle neck and cap is missing or broken. CAUTION: Use only as directed. Do not give to children under six 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.