Anticoagulant Sodium Citrate
Anticoagulant Sodium Citrate
db8334be-5b8b-4811-811a-efbe32b6d147
HUMAN PRESCRIPTION DRUG LABEL
Apr 5, 2024
LABORATORIOS GRIFOLS SA
DUNS: 461842294
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trisodium Citrate Dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 76297-006-03
Anticoagulant Sodium Citrate 4% w/v****
****Solution, USP250 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 XXXXXX EXP YYYY-MM
30 x 250 mL
Num.:
GRIFOLS
Laboratorios Grifols, S. A. SPAIN
LOT: XXXXXX**EXP:**YYYY-MM
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
SPL UNCLASSIFIED SECTION
Laboratorios Grifols, S. A.
SPAIN
Revision: 10/2019
WARNINGS SECTION
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.
STORAGE AND HANDLING SECTION
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.