FDA label 8e3c50ef-5f9e-4c43-bb05-b9531bbd96c8

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: 358bfcf7-10b6-4d56-93ab-6f615c3af6cd
SPL ID: 8e3c50ef-5f9e-4c43-bb05-b9531bbd96c8
Version: 1
Effective date: 2012-11-14
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:23:01

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		8e3c50ef-5f9e-4c43-bb05-b9531bbd96c8	id
spl set id		358bfcf7-10b6-4d56-93ab-6f615c3af6cd	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 Do not use if outer package seal is broken. Stop use and consult a doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, redness or swelling is present in the painful area, or any new symptoms appear. Consult a doctor before use in children younger than 8 years of age.

Reported adverse events (FAERS/openFDA)#

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