FDA label ba1d7b8e-0475-40f3-9fef-5b20fb600ec0

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
0ed2766d-df0b-40c9-82e4-aee35cc0332c
SPL ID
ba1d7b8e-0475-40f3-9fef-5b20fb600ec0
Version
1
Effective date
2013-02-13
Source export date
2026-11-06
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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:59:47

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 Do not use in infants younger than 1 year due to the presence of honey. If pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Reboost or any of its ingredients exists.

Reported adverse events (FAERS/openFDA)#

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