FDA label 353d82c2-080f-4c23-bd31-a98b16846fb2

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: 54f79de3-2e99-49ee-8798-9498a68a44c7
SPL ID: 353d82c2-080f-4c23-bd31-a98b16846fb2
Version: 4
Effective date: 2013-07-31
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:30:50

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		353d82c2-080f-4c23-bd31-a98b16846fb2	id
spl set id		54f79de3-2e99-49ee-8798-9498a68a44c7	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: - Consult a physician before use if pregnant or breast feeding. - Consult a physician if symptoms persist for more than 2 weeks or worsen. - Keep this and all medications out of the reach of children. - Do not use if tamper-evident seal is broken. - In case of accidental overdose, get medical help or contact a Poison Control Center immediately. Keep out of reach of children Keep this and all medications out of the reach of children

Reported adverse events (FAERS/openFDA)#

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