FDA label a3f98f08-bce6-4bd7-a182-36371fc2a6c5

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: c0bd85ac-1114-4a02-b4a0-eb79fb935927
SPL ID: a3f98f08-bce6-4bd7-a182-36371fc2a6c5
Version: 3
Effective date: 2024-11-12
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:59:52

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		a3f98f08-bce6-4bd7-a182-36371fc2a6c5	id
spl set id		c0bd85ac-1114-4a02-b4a0-eb79fb935927	set_id

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings For external use only

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

Distributed by MAJOR PHARMACEUTICALS 31778 ENTERPRISE DRIVE LIVONIA, MI 48150 USA M-97 RE-ORDER NO. 016019 REV 06/13 L0013803FA L0013803BA

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