FDA label f5c47e63-480c-4a89-a873-4fee351dc9ac

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: cc0f4113-e627-4caf-b2d4-95b4106e57f5
SPL ID: f5c47e63-480c-4a89-a873-4fee351dc9ac
Version: 8
Effective date: 2021-12-28
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:12:46

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		f5c47e63-480c-4a89-a873-4fee351dc9ac	id
spl set id		cc0f4113-e627-4caf-b2d4-95b4106e57f5	set_id

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

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

ADVERSE REACTIONS Nausea, abdominal cramps, and diarrhea have been reported inpatients on doses over 3 g daily.

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