{"boxed_warning":["BOXED WARNING NOT FOR DIRECT INJECTION"],"description":["DESCRIPTION Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic."],"effective_time":"20170830","how_supplied":["HOW SUPPLIED Sterile Water for Injection, USP NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25 NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25 NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25 NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN3005 Rev. 1/09"],"how_supplied_table":["<table> <col span=\"1\" width=\"33.333%\"/> <col span=\"1\" width=\"33.333%\"/> <col span=\"1\" width=\"33.333%\"/> <tbody> <tr> <td> NDC 0517-3005-25 </td> <td> 5 mL Single Dose Vial </td> <td> Packaged in 25 </td> </tr> <tr> <td> NDC 0517-3010-25 </td> <td> 10 mL Single Dose Vial </td> <td> Packaged in 25 </td> </tr> <tr> <td> NDC 0517-3020-25 </td> <td> 20 mL Single Dose Vial </td> <td> Packaged in 25 </td> </tr> <tr> <td> NDC 0517-3050-25 </td> <td> 50 mL Single Dose Vial </td> <td> Packaged in 25 </td> </tr> </tbody> </table>"],"id":"5803a98f-e236-2e1b-e053-2991aa0a5c98","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: Sterile Water GENERIC: Water DOSAGE: INJECTION, SOLUTION ADMINSTRATION: INTRAVENOUS NDC: 61786-349-03 ACTIVE INGREDIENT(S): WATER 1mL in 1mL PACKAGING: 20 mL in 1 VIAL, SINGLE-DOSE MM1 MM2 MM3"],"precautions":["PRECAUTIONS Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit."],"set_id":"ce4113dc-1dc6-41d4-ba36-5c512667ba3c","spl_product_data_elements":["Sterile Water Water WATER WATER"],"spl_unclassified_section":["SPL UNCLASSIFIED Rx Only"],"version":"2"}