Indications And Usage
Anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices.
Anticoagulant Sodium Citrate Solution
FDA Label NDC 0338-9669
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Corporation for the product Anticoagulant Sodium Citrate (NDC 0338-9669). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications and usage, administration, dosage forms and strengths, precautions, how supplied, storage and handling, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Administration
The pouch is a moisture barrier. Do not remove from pouch until ready to use. Do not use unless solution is clear and no leaks detected. Do not use unless port protector is in place.
Dosage Forms And Strengths
Anticoagulant Sodium Citrate 4% w/v Solution, USP in the 250 mL single dose container is a sterile solution that contains 4g Sodium Citrate Dihydrate, USP per 100 mL, pH adjusted with citric acid.
Precautions
Not for direct intravenous infusion.
How Supplied
Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton.
Storage And Handling
Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing.
Package/Label Principal Display Panel
Carton Label (Image 01)
LOT
EXP
2B7867
NDC 0338-9669-01
Anticoagulant
Sodium Citrate
4% w/v
Solution USP
Rx only
250 mL EACH 100 mL CONTAINS 4 g SODIUM
CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE NONPYROGENIC
INTENDED FOR USE ONLY WITH AUTOMATED APHERESIS
DEVICES
CAUTION — NOT FOR DIRECT INTRAVENOUS INFUSION THE
POUCH IS A MOISTURE BARRIER DO NOT USE UNLESS
SOLUTION IS CLEAR SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND SINGLE USE CONTAINER DISCARD UNUSED
PORTION DIRECTIONS FOR USE ARE CONTAINED IN THE
OWNERS OPERATING AND MAINTENANCE MANUAL OF THE
APHERESIS MACHINE TO BE USED
RECOMMENDED STORAGE
ROOM TEMPERATURE (25C/77F) AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING.
FOR PRODUCT INFORMATION 1-800-933-0303
BAXTER IS A TRADEMARK OF BAXTER INTERNATIONAL
Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA
07-25-00-4675
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