FDA.reportPublic FDA data

FDA label 8aa7afd4-c994-48bf-b395-9ed9b4accdf3

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
ae8a4be2-3133-419a-89ec-52e44fca6ba0
SPL ID
8aa7afd4-c994-48bf-b395-9ed9b4accdf3
Version
2
Effective date
2026-01-08
Source export date
2026-11-06
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/2026-11-06/d46c999c1947092f6e18e5233482e6d1c02312c89d32ce906e3b19672a696546/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:04:58

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 Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if you are experiencing severe abdominal or chest pain, or if accompanied by a fever. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Reported adverse events (FAERS/openFDA)#

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