FDA label 97b8eaee-7a59-3eb7-e053-2995a90afceb

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
967407b9-621e-4165-a245-11bf577497d6
SPL ID
97b8eaee-7a59-3eb7-e053-2995a90afceb
Version
4
Effective date
2019-11-19
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:11:57

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker ( 5.1 ). 5.1 Radiation Risks Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration ( 2.4 )].

warnings and cautions

5.1 Radiation Risks Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration ( 2.4 )].

Adverse reactions cross-check#

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

adverse reactions

6 ADVERSE REACTIONS No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Zevacor Molecular at 866-364-4478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .