FDA.reportPublic FDA data

FDA label 4aa8321a-3ff3-4b91-bdc8-7bddb1cdc2a9

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
e9ef06a5-5a61-47df-9203-2573454c0591
SPL ID
4aa8321a-3ff3-4b91-bdc8-7bddb1cdc2a9
Version
21
Effective date
2023-10-31
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:34:48

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Because of the benzyl alcohol content, caution should be used in administration to newborns, particularly infants born prematurely, and individuals with impaired liver function. The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Severe itching, erythema, and rash were observed in one patient of 300 studied. The rare occurrence of hypersensitivity reactions or allergic reactions, skin rash, and nausea have been reported in association with Gallium 67 use.

Reported adverse events (FAERS/openFDA)#

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