Anticoagulant Sodium Citrate 4% W/V Solution Usp
Rx only 250 mL
Intended for use only with automated apheresis devices.
Each 100 mL contains:
Sodium Citrate (Dihydrate), USP 4.0 g
(pH adjusted with Citric Acid, Monohydrate, USP)
Anticoagulant Sodium Citrate Solution
FDA Label NDC 76297-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Grifols Sa for the product Anticoagulant Sodium Citrate (NDC 76297-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding anticoagulant sodium citrate 4% w/v solution usp, caution, other, recommended storage:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Caution
Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.
Other
STERILE, nonpyrogenic fluid path.
Laboratorios Grifols, S. A.
SPAIN
Revision: 10/2019
Recommended Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.
Package Label.Principal Display Panel
NDC 76297-006-01
Anticoagulant Sodium Citrate 4% w/v
Solution, USP 250 mL
Rx Only
Intended for use only with automated apheresis devices.
Not for direct intravenous infusion.
RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Brief exposure up to 40°C (104°F) does not adversely affect the product.
Protect from freezing.
LOT EXP 1001344
28 x 250 mL
Num.:
GRIFOLS
Laboratorios Grifols, S. A. SPAIN
LOT
EXP
NDC 76297-006-02
Anticoagulant Sodium Citrate 4% w/v
Solution, USP 250 mL
Rx Only
Intended for use only with automated apheresis devices
Each 100 mL contains:
Sodium Citrate (Dihydrate), USP 4.0 g
(ph adjusted with Citric Acid, Monohydrate, USP)
Caution: Not for direct intravenous infusion. The pouch is a moisture barrier.
Do not use unless solution is clear and no leaks detected. Single use container.
Discard unused portion.
STERILE, nonpyrogenic fluid path.
RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.
Laboratorios Grifols, S. A. SPAIN
GRIFOLS
Carton (Container 76297 006 02)
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