Sterile Water
- Manufacturer
- Hikma Farmaceutica | Hikma Pharmaceuticals USA Inc.
- Effective date
- 2023-05-08
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:31:45
Label at a glance#
ProductSterile Water
Active ingredientWATER
Label structure3 sections
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
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.
PRINCIPAL DISPLAY PANEL
Sterile Water for Injection, USP inner bag
PRINCIPAL DISPLAY PANEL
Sterile Water for Injection, USP overwrap
Products#
Every source-derived product name is available through these pages.
- Sterile Water
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62778-347 | 62778-347-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a5ce5c62-2cde-4040-8c80-38e5b3ff8b6c | f45e5cda-8d11-4308-95d1-7520c531a668 | 2024-02-09 | Adverse reactions | f45e5cda-8d11-4308-95d1-7520c531a668 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.