Label: ACD-A- anticoagulant citrate dextrose solution formula a solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 6, 2013

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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

    RECOMMENDED STORAGE–STORE AT CONTROLLED ROOM TEMPERATURE.

    CODE 4B7891X
    NDC 0942-0641-04

    1000 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

    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
    Deerfield, IL 60015 USA

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

    07-25-58-006         Made in USA

    LABEL ISSUE DATE    05/2008

  • PACKAGE/LABEL DISPLAY PANEL

    Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A label

  • INGREDIENTS AND APPEARANCE
    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 Monohydrate24.5 g  in 1000 mL
    Sodium Citrate (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) Sodium Citrate22 g  in 1000 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid7.3 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0942-0641-041000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN16091803/01/2007
    Labeler - Fenwal Inc (794519020)