FDA label 0428288d-4064-e853-e063-6294a90adb0c

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: 81dfb974-e96b-caba-e053-2a91aa0ab7f4
SPL ID: 0428288d-4064-e853-e063-6294a90adb0c
Version: 5
Effective date: 2023-01-01
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:39:22

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		0428288d-4064-e853-e063-6294a90adb0c	id
spl set id		81dfb974-e96b-caba-e053-2a91aa0ab7f4	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 Stop use and ask a doctor if symptoms persist, worsen, reoccur or are severe you experience fever, chills, back pain, or bloody urine an allergic reaction occurs, seek medical help right away If pregnant or breastfeeding, ask a health professional before use. Keep this and all medicines out of the reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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