FDA label f46dd30f-ea92-4d63-8501-47d8c3de2fd6

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: 94b5e087-12fc-48af-8c66-58d57f16c8da
SPL ID: f46dd30f-ea92-4d63-8501-47d8c3de2fd6
Version: 3
Effective date: 2015-12-17
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:23:14

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		f46dd30f-ea92-4d63-8501-47d8c3de2fd6	id
spl set id		94b5e087-12fc-48af-8c66-58d57f16c8da	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. KEEP OUT OF REACH OF CHILDREN. 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.