FDA label 5cf0dfbc-2418-4812-e053-2991aa0aaea4

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: 3b96e86b-d029-45d2-ae6b-826245e1ff12
SPL ID: 5cf0dfbc-2418-4812-e053-2991aa0aaea4
Version: 2
Effective date: 2017-11-01
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 06:11:37

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		5cf0dfbc-2418-4812-e053-2991aa0aaea4	id
spl set id		3b96e86b-d029-45d2-ae6b-826245e1ff12	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 Ask a doctor before use if pregnant or nursing. Consult a physician if symptoms persist for more than 7 days or worsen. Keep this and all medications out of the reach of children. Do not use if imprinted tamper band is broken or missing. In case of accidental overdose, contact a poison control center immediately. In case of emergency, the manufacturer may be contacted 24 hours a day, 7 days a week at 800/624-9659.

Reported adverse events (FAERS/openFDA)#

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