Home FDA labels 3294fc9f-5dca-48f4-b976-db06ac986d26 FDA label 3294fc9f-5dca-48f4-b976-db06ac986d26 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 3294fc9f-5dca-48f4-b976-db06ac986d26
SPL ID 3294fc9f-5dca-48f4-b976-db06ac986d26
Version 1
Effective date 2009-12-15
Source export date 2026-10-12
Source partition 1
Source file https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:26:14 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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS: The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. Mental confusion or depression can occur due to intolerance or overdosage of butalbital. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.