FDA label df7fe785-d943-4767-895b-f1e1c6135059

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: b1f38e0d-39bc-44ba-bddc-bf185eec0b5e
SPL ID: df7fe785-d943-4767-895b-f1e1c6135059
Version: 2
Effective date: 2022-08-31
Source export date: 2026-10-22
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/2026-10-22/900f57228a266ed4fd8a11e78d75ce718639346ea99b90befe9f294809712917/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 00:49:36

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		df7fe785-d943-4767-895b-f1e1c6135059	id
spl set id		b1f38e0d-39bc-44ba-bddc-bf185eec0b5e	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: Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. If pregnant or nursing, seek the advice of a health professional before use. If symptoms persist or recur, consult your health practitioner. Symptoms often become acute between the second and fourth dose as part of the normal healing process. It is recommended to continue Series Therapy until completion for best results. Tamper seal: Sealed for your protection. DO NOT USE IF SEAL IS BROKEN OR MISSING.

Reported adverse events (FAERS/openFDA)#

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