ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. No adverse reactions have been reported for Ammonia 13 Injection based on 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 13 Injection based on review of the published literature, publicly available reference sources, and adverse drug reaction reporting system(6).To report SUSPECTED ADVERSE REACTIONS, contact Kreitchman PET Center at 212-305-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

product label.

SPL UNCLASSIFIED SECTION.

Manufactured by: Kreitchman PET Center, 722 168th Street, R-1 Level Room 110, New York, NY 10032Distributed by: Kreitchman PET Center, 722 168th Street, R-1 Level Room 110, New York, NY 10032.