FDA label b1ed2fb0-6df5-4a31-8655-29db9713a047

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
4f2d8e2d-2f3b-40a2-a973-dee477a2c2d5
SPL ID
b1ed2fb0-6df5-4a31-8655-29db9713a047
Version
5
Effective date
2019-08-20
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 01:26:20

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

WARNING WARNINGS: STOP USE AND CALL A DOCTOR if symptoms persist or worsen. CONTAINS ALCOHOL: in case of accidental overdose, consult a poison control center immediately IF PREGNANT OR BREAST FEEDING, consult a healthcare professional before use. OTHER INFORMATION: Tamper resistant for your protection. Use only if safety seal is intact.

Reported adverse events (FAERS/openFDA)#

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