FDA label b76a0c0a-cd16-4ff6-b17e-9a42b11ab6f6

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: fd964c61-4ab4-4865-8607-811c4d394030
SPL ID: b76a0c0a-cd16-4ff6-b17e-9a42b11ab6f6
Version: 2
Effective date: 2014-04-30
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:59:48

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		b76a0c0a-cd16-4ff6-b17e-9a42b11ab6f6	id
spl set id		fd964c61-4ab4-4865-8607-811c4d394030	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

WARNING: Do not use if seal is broken. If you are pregnant or nursing, consult your health care practitioner before use. Store in a cool, dry place. If symptoms persist or worsen, discontinue use and contact a licensed health care practitioner. KEEP OUT OF THE REACH OF CHILDREN. INACTIVE INGREDIENT: Sucrose. Lactose - free.

Reported adverse events (FAERS/openFDA)#

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