Anticoagulant Sodium Citrate Solution Usp

Anticoagulant Sodium Citrate Solution Usp
SPL v5
SPL
SPL Set ID a63da38d-1fea-4ee0-a70b-55c891a5ebcc
Route
INTRAVENOUS
Published
Effective Date 2022-02-11
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (4 g)
Inactive Ingredients
Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
NDA Active Since 2007-03-01

Description

A standalone direction insert does not exist for this product.


Medication Information

Description

A standalone direction insert does not exist for this product.

Package/label Display Panel

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

CODE 4B7867Q

NDC 0942-9505-10

250 mL

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP

pH ADJUSTED WITH CITRIC ACID

STERILE

NONPYROGENIC

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

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

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

PL 146 PLASTIC

MANUFACTURED BY:

BAXTER HEALTHCARE CORPORATION

DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.

LAKE ZURICH, IL 60047 USA

MADE IN USA

07-25-02-996 REV: C

Anticoagulant Sodium Citrate Solution Usp

A standalone direction insert does not exist for this product.


Structured Label Content

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

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

CODE 4B7867Q

NDC 0942-9505-10

250 mL

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP

pH ADJUSTED WITH CITRIC ACID

STERILE

NONPYROGENIC

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

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

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

PL 146 PLASTIC

MANUFACTURED BY:

BAXTER HEALTHCARE CORPORATION

DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.

LAKE ZURICH, IL 60047 USA

MADE IN USA

07-25-02-996 REV: C

Anticoagulant Sodium Citrate Solution Usp (Anticoagulant Sodium Citrate Solution USP)

A standalone direction insert does not exist for this product.


Advanced Ingredient Data


Raw Label Data

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