Acd-a Solution
FDA Label NDC 0942-0641

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 Acd-a (NDC 0942-0641). 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 anticoagulant citrate dextrose solution usp (acd) formula a, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Anticoagulant Citrate Dextrose Solution Usp (Acd) Formula A

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

RECOMMENDED STORAGE–STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7891X
NDC 0942-0641-04

1000 mL

Fenwal™

Rx only

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP

STERILE

NONPYROGENIC

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

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

Rx only

PL 146 PLASTIC

Manufactured by:
Baxter Healthcare Corporation
65 Pitts Station Rd.

Marion, NC 28752

USA

Logo (Image 01)

Logo (Image 01)

Manufactured for:
Fenwal, Inc.
Lake Zurich, IL 60047 USA

Fenwal P/N072516810         Made in USA

LABEL ISSUE DATE    07/2023

07-25-00-4194

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