FDA label ccf9ac38-566e-4fe2-86c7-0b62b52153fc

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: 5a443fa3-a38f-4e4e-b6a0-7773a3d5ec83
SPL ID: ccf9ac38-566e-4fe2-86c7-0b62b52153fc
Version: 3
Effective date: 2016-08-16
Source export date: 2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:03:52

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		ccf9ac38-566e-4fe2-86c7-0b62b52153fc	id
spl set id		5a443fa3-a38f-4e4e-b6a0-7773a3d5ec83	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 ever had allergic reaction to this product or any of it's ingredients Do not use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor before use if you have do not take more than directed. Taking more than directed may cause drowsiness. When using this product an allergic reaction to this product occurs. Seek medical help right away. Stop use and ask a doctor if , ask a health professional before use. If pregnant or breast-feeding . In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children

Reported adverse events (FAERS/openFDA)#

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