Home FDA labels 488670e8-c373-4597-ae52-eab3d7736eb4 FDA label 488670e8-c373-4597-ae52-eab3d7736eb4 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 488670e8-c373-4597-ae52-eab3d7736eb4
SPL ID 488670e8-c373-4597-ae52-eab3d7736eb4
Version 1
Effective date 2010-05-10
Source export date 2026-08-17
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-17/c175bb03f5d8cc04ea33f7568ffa188cf4a6af159fe9da540d52ee57505d2752/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run 20260818T065550Z
Imported at 2026-08-18 07:56:13 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 *Based on a review of this drug (isometheptene mucate) by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the other indication as "possibly" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation.
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: Hypersensitive patients have shown rash and transient dizziness; this can be eliminated by reducing dosage.