FDA.reportPublic FDA data

FDA label b71350e1-f967-16cb-e053-2a95a90a3206

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
d0749234-5c63-4a48-8846-130f38a25fa0
SPL ID
b71350e1-f967-16cb-e053-2a95a90a3206
Version
3
Effective date
2020-12-22
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:26

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). As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Stop use and ask a doctor if symptoms persist, return or get worse KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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