FDA label fd0677ba-1a4e-4d2c-aef0-73d6ebeade55

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: f0942edb-cb93-41f9-8ae5-df669df94db4
SPL ID: fd0677ba-1a4e-4d2c-aef0-73d6ebeade55
Version: 2
Effective date: 2026-05-15
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:06:53

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		fd0677ba-1a4e-4d2c-aef0-73d6ebeade55	id
spl set id		f0942edb-cb93-41f9-8ae5-df669df94db4	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: If pregnant or breast feeding, seek the advice of a doctor before use. Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor is symptoms persist, worsen or if new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do Not use if tamper evident seal around neck of bottle is missing or broken.

Reported adverse events (FAERS/openFDA)#

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