{"adverse_reactions":["ADVERSE REACTIONS The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689."],"effective_time":"20240209","id":"a5ce5c62-2cde-4040-8c80-38e5b3ff8b6c","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Sterile Water for Injection, USP inner bag Inner bag","PRINCIPAL DISPLAY PANEL Sterile Water for Injection, USP overwrap overwrap"],"set_id":"f45e5cda-8d11-4308-95d1-7520c531a668","spl_product_data_elements":["Sterile Water Sterile Water WATER WATER"],"version":"4"}