FDA.reportPublic FDA data

FDA label 2d296930-2147-624d-e054-00144ff88e88

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
1e121c5d-bd6e-047f-e054-00144ff8d46c
SPL ID
2d296930-2147-624d-e054-00144ff88e88
Version
4
Effective date
2016-03-03
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 05:23:08

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warning Section Warnings Ask a doctor before use in children under 5 years of age. Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. If pregnant or breastfeeding, ask a doctor before use. Keep out of reach of children.

warnings and cautions

Warning and Precautions Section WarningsAsk a doctor before use in children under 5 years of age. Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. If pregnant or breastfeeding, ask a doctor before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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