FDA label d5ec9af0-b2a0-47cd-a418-cfc00df2afd8

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: 244e041f-20e2-4e38-ac6b-bf96f8724d5e
SPL ID: d5ec9af0-b2a0-47cd-a418-cfc00df2afd8
Version: 1
Effective date: 2012-09-25
Source export date: 2026-11-06
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:57:50

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		d5ec9af0-b2a0-47cd-a418-cfc00df2afd8	id
spl set id		244e041f-20e2-4e38-ac6b-bf96f8724d5e	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 you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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