FDA label ea6128bb-29d8-4373-b6be-e1f24a6efb13

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
f77e0d17-44de-4ac0-84a4-dcb3cb83cd33
SPL ID
ea6128bb-29d8-4373-b6be-e1f24a6efb13
Version
3
Effective date
2012-04-05
Source export date
2026-11-06
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:08:38

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 Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or nursing, take only on advice of physician. Keep this and all medication out of reach of children. Tamper resistant for your protection. Use only if safety seal is intact. Caution: Federal Law prohibits dispensing without prescription. Reference image forte.jpg

Reported adverse events (FAERS/openFDA)#

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