FDA label 467fa578-bb0b-48dd-b5e2-36e5e9829c96

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: f14b202e-56bd-4477-84c9-2d99ac38c111
SPL ID: 467fa578-bb0b-48dd-b5e2-36e5e9829c96
Version: 1
Effective date: 2012-10-15
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:50:06

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		467fa578-bb0b-48dd-b5e2-36e5e9829c96	id
spl set id		f14b202e-56bd-4477-84c9-2d99ac38c111	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.

Reported adverse events (FAERS/openFDA)#

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