SPL v7
SPL
SPL Set ID ab19b011-0a51-4f04-9881-d9fc7cae95ae
Route
INTRAVENOUS
Published
Effective Date 2025-11-25
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dextrose (24.5 g) Anhydrous Citric Acid (22 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2007-03-01
Description

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 Manufactured for: Fenwal, Inc. Lake Zurich, IL 60047 USA Fenwal P/N072516810         Made in USA LABEL ISSUE DATE    07/2023 07-25-00-4194

Medication Information

Description

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 Manufactured for: Fenwal, Inc. Lake Zurich, IL 60047 USA Fenwal P/N072516810         Made in USA LABEL ISSUE DATE    07/2023 07-25-00-4194

Package/label Display Panel
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

Manufactured for:

Fenwal, Inc.

Lake Zurich, IL 60047 USA

Fenwal P/N072516810         Made in USA

LABEL ISSUE DATE    07/2023

07-25-00-4194

Structured Label Content

Package/label Display Panel (PACKAGE/LABEL DISPLAY PANEL)
Anticoagulant Citrate Dextrose Solution Usp (acd) Formula A (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

Manufactured for:

Fenwal, Inc.

Lake Zurich, IL 60047 USA

Fenwal P/N072516810         Made in USA

LABEL ISSUE DATE    07/2023

07-25-00-4194

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:50:32.710886 · Updated: 2026-03-14T22:37:51.668409