FDA label 46e1b15d-cf7c-6b90-e063-6394a90a3b57

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: 62978d57-4cab-8280-e053-2a91aa0ac9db
SPL ID: 46e1b15d-cf7c-6b90-e063-6394a90a3b57
Version: 3
Effective date: 2025-12-26
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:15

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		46e1b15d-cf7c-6b90-e063-6394a90a3b57	id
spl set id		62978d57-4cab-8280-e053-2a91aa0ac9db	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 sue if you have a known allergy or sensitivity to any of the ingredients. Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash. As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.

Reported adverse events (FAERS/openFDA)#

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