Drug Labeling and Warnings

Drug Details

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ACD-A- anticoagulant citrate dextrose solution formula a solution 
Fenwal Inc

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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:

logoFenwal, 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0942-0641
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate12.25 g  in 500 mL
Sodium Citrate (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) Sodium Citrate11 g  in 500 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid3.65 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0942-0641-03500 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDABN16091803/01/2007
Labeler - Fenwal Inc (794519020)

Revised: 5/2013
 
Fenwal Inc


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