FDA label 09d5e46e-c065-4d67-9bed-28c0f19c4dd0

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: c415fa34-9769-4a98-925e-33307c74c55d
SPL ID: 09d5e46e-c065-4d67-9bed-28c0f19c4dd0
Version: 6
Effective date: 2025-03-28
Source export date: 2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:11:07

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		09d5e46e-c065-4d67-9bed-28c0f19c4dd0	id
spl set id		c415fa34-9769-4a98-925e-33307c74c55d	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 OTC - DO NOT USE Do not use if you have ever had an allergic reaction to this product or any of its ingredients. OTC - ASK DOCTOR Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. OTC - WHEN USING When using this product do not take more than directed. Taking more than directed may cause drowsiness. OTC - STOP USE Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. OTC - PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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