Sodium Citrate Blood-pack Units, (pl 146 Plastic) Solution
FDA Label NDC 0942-9506

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fenwal, Inc. for the product Sodium Citrate Blood-pack Units, (pl 146 Plastic) (NDC 0942-9506). 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 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

Package/Label Principal Display Panel

CODE 6B7801
NDC 0942-9506-25
250mL

Fresenius Kabi                                                                             Rx only


ANTICOAGULANT SODIUM CITRATE SOLUTION USP

NOT FOR DIRECT INTRAVENOUS INFUSION
EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID

STERILE NONPYROGENIC FOR USE WITH APHERESIS DEVICE ONLY
SINGLE USE CONTAINER DISCARD UNUSED PORTION DO NOT USE
UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED
AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING
INNER BAG FIRMLY IF LEAKS ARE FOUND DISCARD SOLUTION AS
STERILITY MAY BE IMPAIRED

CAUTION – DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY
FOR USE THE OVERWRAP IS A MOISTURE BARRIER THE INNER BAG
MAINTAINS THE STERILITY OF THE PRODUCT STORE AT CONTROLLED
ROOM TEMPERATURE

FRESENIUS KABI AG
61346 BAD HOMBURG / GERMANY

TEL.: +49 (0)6172 686-0
www.fresenius-kabi.com

Made in MX                                                                               47-25-13-348 REV: A

Packlbl6b7801 (Package Label)

Packlbl6b7801 (Package Label)

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