FDA.reportPublic FDA data

FDA label e98ce900-85a2-44ec-ac6c-b80910903ad8

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
f98e50da-d384-4189-8e7f-fd45a8b2f532
SPL ID
e98ce900-85a2-44ec-ac6c-b80910903ad8
Version
2
Effective date
2013-07-10
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:09

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 Ask a doctor before use if pregnant or nursing child is taking any prescription medicines. Keep this and all medications out of the reach of children. Do not use if imprinted tamper band is broken or missing. In case of accidental overdose, contact a poison control center immediately. If symptoms don't improve within 7 days, discontinue use and seek the advice of a licensed medical practitioner. In case of emergency, the manufacturer may be contacted 24 hours a day, 7 days a week at 800/624-9659.

Reported adverse events (FAERS/openFDA)#

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