FDA label f353b617-3ee9-4b95-aa43-b2c0674a808a

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: a3264947-af0e-4e9d-b875-711d0b81beb4
SPL ID: f353b617-3ee9-4b95-aa43-b2c0674a808a
Version: 3
Effective date: 2015-12-17
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:33:09

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		f353b617-3ee9-4b95-aa43-b2c0674a808a	id
spl set id		a3264947-af0e-4e9d-b875-711d0b81beb4	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: For Adults only. Do not use if pregnant or breast-feeding. Cancer, heart, diabetes patients must consult a physician before taking this product. In case of overdose, get medical help or contact a Poison Control Center right away. THIS TAMPER EVIDENT BOTTLE HAS A SEAL AROUND THE NECK OF THE BOTTLE AND CONSUMERS SHOULD NOT USE IF THIS SEAL IS BROKEN OR MISSING.

Reported adverse events (FAERS/openFDA)#

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