FDA label c1351844-fcf0-4f13-ab0a-d982287c1eef

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
59390fa8-fd99-4c00-948b-3e202ce58e7c
SPL ID
c1351844-fcf0-4f13-ab0a-d982287c1eef
Version
3
Effective date
2025-05-21
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:38:03

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: Not intended for persons under the age of 18. If pregnant or breast-feeding, do not use Consult a health professional prior to use if you have any pre-existing medical conditions or take any prescription medications. Do not consume with any caffeine or stimulants. Improper use will not improve results and is potentially hazardous to a person's health. Use only as directed. Keep out of 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 is broken or missing. To report a serious adverse event or obtain product information, please call 1-866-607-2768.

Reported adverse events (FAERS/openFDA)#

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