SPL v3
SPL
SPL Set ID 14b238ab-904b-45dc-9eb9-a1074364e089
Route
INTRAVENOUS
Published
Effective Date 2022-11-07
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2014-09-29

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 Principal Display Panel

CODE 6B7801

NDC 0942-9506-25

250mL

Fresenius Kabi                                                                             Rx only



ANTICOAGULANT SODIUM CITRATE SOLUTION USP

NOT FOR DIRECT INTRAVENOUS INFUSION

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

pH ADJUSTED WITH CITRIC ACID



STERILE NONPYROGENIC FOR USE WITH APHERESIS DEVICE ONLY

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



FRESENIUS KABI AG

61346 BAD HOMBURG / GERMANY

TEL.: +49 (0)6172 686-0

www.fresenius-kabi.com



Made in MX                                                                               47-25-13-348 REV: A



Anticoagulant Sodium Citrate Solution Usp

A standalone direction insert does not exist for this product.


Structured Label Content

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

CODE 6B7801

NDC 0942-9506-25

250mL

Fresenius Kabi                                                                             Rx only



ANTICOAGULANT SODIUM CITRATE SOLUTION USP

NOT FOR DIRECT INTRAVENOUS INFUSION

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

pH ADJUSTED WITH CITRIC ACID



STERILE NONPYROGENIC FOR USE WITH APHERESIS DEVICE ONLY

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



FRESENIUS KABI AG

61346 BAD HOMBURG / GERMANY

TEL.: +49 (0)6172 686-0

www.fresenius-kabi.com



Made in MX                                                                               47-25-13-348 REV: A



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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