FDA.reportPublic FDA data

FDA label 2d27f6dc-75c9-57e4-e054-00144ff8d46c

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
158502c9-5f5e-1de2-e054-00144ff88e88
SPL ID
2d27f6dc-75c9-57e4-e054-00144ff8d46c
Version
2
Effective date
2016-03-03
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:14

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 udner three years oage. Stop use and ask a doctor if symptoms persist for more than three days or worsen. If pregnant or breastfeeding, ask a doctor before use. Keep out of reach of children. Do not use to treat food allergies.

warnings and cautions

Warning and Precautions Section Warnings Ask a doctor before use in children under 3 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. Do not use to treat food allergies.

Reported adverse events (FAERS/openFDA)#

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