FDA label b6f99656-b1b7-4dcf-8dab-1f456accbbd8

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
ca62324a-cb1a-4bd5-96c5-23c412d180e5
SPL ID
b6f99656-b1b7-4dcf-8dab-1f456accbbd8
Version
2
Effective date
2018-09-10
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:48

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 you are pregnant, may become pregnant, or breastfeeding, consult your health care professional before using this product. Stop use and consult your physician if symptoms persist for more than 3 days or worsen. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper-evident seal of broken or missing.

Reported adverse events (FAERS/openFDA)#

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