FDA label f83805f1-4c44-4ee7-9a2c-1a0032d49da2

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
f50b167c-9ed5-4c01-ab50-d8e823d53ad3
SPL ID
f83805f1-4c44-4ee7-9a2c-1a0032d49da2
Version
2
Effective date
2018-03-01
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:06

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 TAMPER EVIDENT: Each tablet is individually sealed. Do not use if blister or foil is broken, torn, or missing. For institutional use only. This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.

Reported adverse events (FAERS/openFDA)#

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