Home FDA labels b88e6bbf-2904-45c4-b8c2-e3f1befbd4b5 FDA label b88e6bbf-2904-45c4-b8c2-e3f1befbd4b5 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 96b7e547-e0a7-4931-873a-f2e5967bfd6e
SPL ID b88e6bbf-2904-45c4-b8c2-e3f1befbd4b5
Version 15
Effective date 2013-06-20
Source export date 2026-11-06
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/5781d2d281f00c57d2634422e88d204f4ab5cf8444979f7006f538b3a4f26d3b/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run 20261106T075659Z
Imported at 2026-11-06 08:37:27 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Boxed warning cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Boxed warning sections page 1 of 1 · 1 matching rows.
boxed warning WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION ).
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.