Sterile Water
Sterile Water for Injection, USP
6990b809-8873-4a2c-b7cd-c0387765cb7f
HUMAN PRESCRIPTION DRUG LABEL
Jul 18, 2023
Nexus Pharmaceuticals Inc
DUNS: 620714787
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Water
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Water
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 20 mL Vial Label
NDC 14789-132-07
Rx Only
Sterile Water for
Injection, USP
For Drug Diluent Use Only
WARNINGS: NOT ISOTONIC,
HEMOLYTIC
Do not give intravenously
unless rendered nearly isotonic
20 mL Single-dose Vial
NEXUS
PHARMACEUTICALS
PRECAUTIONS SECTION
PRECAUTIONS
Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.
Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Drug Interactions
Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.
Use aseptic technique for single or multiple entry and withdrawal from all containers.
When diluting or dissolving drugs, mix thoroughly and use promptly.
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.
Do not use unless the solution is clear and seal intact. Do not reuse single- dose containers. Discard unused portion.