FDA label c8719688-b3b7-40ea-b89b-5c7d9a884426

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
43aa1240-e83f-40ba-99c9-285e367af46a
SPL ID
c8719688-b3b7-40ea-b89b-5c7d9a884426
Version
8
Effective date
2011-06-10
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:28

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.