FDA.reportPublic FDA data

FDA label a0d8f375-915c-49ef-ba74-40c42434dbec

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
572113de-8469-4dd9-9f0e-d368e87434e5
SPL ID
a0d8f375-915c-49ef-ba74-40c42434dbec
Version
2
Effective date
2022-08-30
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:08:37

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: Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. If pregnant or nursing, seek the advice of a health professional before use. If symptoms persist or recur, consult your health practitioner. Symptoms often become acute between the second and fourth dose as part of the normal healing process. It is recommended to continue Series Therapy until completion for best results. Tamper seal: Sealed for Your Protection. DO NOT USE IF SEAL IS BROKEN OR MISSING.

Reported adverse events (FAERS/openFDA)#

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