FDA label 8b038f91-aa93-458f-bc04-0ed1ed834604

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: 22fc75d7-617c-4d64-b6d1-11b19d5b1a9d
SPL ID: 8b038f91-aa93-458f-bc04-0ed1ed834604
Version: 3
Effective date: 2019-01-03
Source export date: 2026-10-12
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:48:13

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		8b038f91-aa93-458f-bc04-0ed1ed834604	id
spl set id		22fc75d7-617c-4d64-b6d1-11b19d5b1a9d	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 • this product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI) Do not use if you have • allergic reactions to any of the ingredients in this product Ask a doctor before use if you have • diabetes Stop use and ask a doctor if • symptoms persist, return or get worse 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.