FDA label 50b218ca-477a-f166-e063-6394a90a807a

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: de5fa19f-25d9-ba81-e053-2a95a90af82f
SPL ID: 50b218ca-477a-f166-e063-6394a90a807a
Version: 4
Effective date: 2026-04-30
Source export date: 2026-10-12
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:12:07

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		50b218ca-477a-f166-e063-6394a90a807a	id
spl set id		de5fa19f-25d9-ba81-e053-2a95a90af82f	set_id

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 Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product, do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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