FDA Label for Anticoagulant Sodium Citrate
View Indications, Usage & Precautions
Anticoagulant Sodium Citrate Product Label
The following document was submitted to the FDA by the labeler of this product Laboratorios Grifols Sa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
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
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