FDA label d42a34ec-7898-fa0c-e053-2a95a90a1564

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: 1bf94dc7-f733-46a1-a07f-78d94552c210
SPL ID: d42a34ec-7898-fa0c-e053-2a95a90a1564
Version: 3
Effective date: 2021-12-27
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:22:48

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		d42a34ec-7898-fa0c-e053-2a95a90a1564	id
spl set id		1bf94dc7-f733-46a1-a07f-78d94552c210	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 tamper band is broken or missing. For external use only. If symptoms persist for more than 7 days or worsen, consult a licensed health care professional. Keep this and all medications out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product. In case of accidental overdose, contact a poison control center immediately. In case of emergency, the manufacturer may be reached 24 hours a day.

Reported adverse events (FAERS/openFDA)#

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