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:

logo Fenwal, Inc.
Lake Zurich, IL 60047 USA

PACKAGE/LABEL DISPLAY PANEL

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A label [Enter Package/Label Display Panel here]

ACD-A
anticoagulant citrate dextrose solution formula a solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0942-0641
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose Monohydrate	12.25 g in 500 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL)	SODIUM CITRATE, UNSPECIFIED FORM	11 g in 500 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	3.65 g in 500 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0942-0641-03	500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN160918	03/01/2007

Labeler - Fenwal, Inc. (794519020)

Registrant - Fenwal, Inc. (794519020)

Name	Address	ID/FEI	Business Operations
Establishment
Baxter Healthcare Corporation		059140764	MANUFACTURE(0942-0641)