FDA label 50133413-31dc-7ae3-e063-6394a90a4031

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
a4fc6445-40c0-73ef-e053-2995a90ae6a4
SPL ID
50133413-31dc-7ae3-e063-6394a90a4031
Version
5
Effective date
2026-04-22
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:28:39

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 Ask a doctor before use if you have ■ never had migraines diagnosed by a health professional. ■ a headache that is different from your usual migraines. ■ the worst headache of your life. ■ fever and stiff neck. ■ headaches beginning after or caused by head injury, exertion, coughing or bending. ■ experienced your first headache after the age of 50. ■ daily headaches.  a migraine so severe as to require bed rest. ■ been vomiting with your migraine headache. Stop use and ask a doctor if ■ an allergic reaction occurs. ■ you feel faint. ■ your migraine is not relieved or worsens after first dose. ■ new or unexpected symptoms occur. ■ ringing in the ears or loss of hearing occurs. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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