SPL v6
SPL
SPL Set ID 22805f0d-ba58-41ea-b245-19980abcda22
Route
INTRAVENOUS
Published
Effective Date 2022-02-11
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dextrose (12.25 g) Anhydrous Citric Acid (11 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 STORE AT CONTROLLED ROOM TEMPERATURE CODE 4B7898Q NDC 0942-0641-03 500 mL Fenwal™ 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 STERILIZED BY STEAM 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 DISPOSE OF CONTAINER APPROPRIATELY SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION Rx only PL 146 PLASTIC Manufactured by: Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752 MADE IN USA 07-25-57-867 REV: B Manufactured for: Fenwal, Inc. Lake Zurich, IL 60047 USA


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 STORE AT CONTROLLED ROOM TEMPERATURE CODE 4B7898Q NDC 0942-0641-03 500 mL Fenwal™ 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 STERILIZED BY STEAM 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 DISPOSE OF CONTAINER APPROPRIATELY SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION Rx only PL 146 PLASTIC Manufactured by: Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752 MADE IN USA 07-25-57-867 REV: B Manufactured for: Fenwal, Inc. Lake Zurich, IL 60047 USA

Package/label Display Panel

[Enter Package/Label Display Panel here]

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

STORE AT CONTROLLED ROOM TEMPERATURE

CODE 4B7898Q

NDC 0942-0641-03

500 mL

Fenwal™

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

STERILIZED BY STEAM

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

DISPOSE OF CONTAINER APPROPRIATELY

SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION

Rx only

PL 146 PLASTIC

Manufactured by:

Baxter Healthcare Corporation

65 Pitts Station Road

Marion, North Carolina 28752

MADE IN USA 07-25-57-867 REV: B

Manufactured for:

Fenwal, Inc.

Lake Zurich, IL 60047 USA


Structured Label Content

Package/label Display Panel (PACKAGE/LABEL DISPLAY PANEL)

[Enter Package/Label Display Panel here]

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

STORE AT CONTROLLED ROOM TEMPERATURE

CODE 4B7898Q

NDC 0942-0641-03

500 mL

Fenwal™

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

STERILIZED BY STEAM

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

DISPOSE OF CONTAINER APPROPRIATELY

SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION

Rx only

PL 146 PLASTIC

Manufactured by:

Baxter Healthcare Corporation

65 Pitts Station Road

Marion, North Carolina 28752

MADE IN USA 07-25-57-867 REV: B

Manufactured for:

Fenwal, Inc.

Lake Zurich, IL 60047 USA


Advanced Ingredient Data


Raw Label Data

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