Acd Injection, Solution
FDA Label NDC 14537-967

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Terumo Bct Ltd for the product Acd (NDC 14537-967). 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 other, description, caution, recommended storage, how supplied, principal display panel - 12 bag case label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Catalog # 777967-000
12 × 750 mL units

NDC 14537-967-75

Manufactured by Terumo BCT, Inc.
10811 W Collins Avenue, Lakewood CO 80215, USA

777967-065

Lot
Expiry Date

Description

Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx Only. Single use container.

Discard unused portion. For use only with apheresis devices.

See apheresis device operator's manual for complete instructions.

Caution

Not for direct intravenous infusion.

Room temperature (25°C).

Avoid excessive heat. Protect from freezing.

How Supplied

Each 100 mL contains:
Dextrose Monohydrate USP2.45 g
Sodium Citrate Dihydrate USP2.20 g
Citric Acid Monohydrate USP
In Water for Injection USP
0.80 g

Principal Display Panel - 12 Bag Case Label

Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution A

Catalog # 777967-000
12 x 750 mL units

NDC 14537-967-75

Sterile. Non-pyrogenic. Do not use unless the solution is clear
and the container is intact. Rx Only. Single use container.
Discard unused portion. For use only with apheresis devices.
See apheresis device operator's manual for complete instructions.

Caution: Not for direct intravenous infusion.

Recommended storage: Room temperature (25°C).
Avoid excessive heat. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP 2.45 g
Sodium Citrate Dihydrate USP 2.20 g
Citric Acid Monohydrate USP 0.80 g
In Water for Injection USP

Manufactured by Terumo BCT, Inc.
10811 W Collins Avenue, Lakewood CO 80215, USA

777967-065

TERUMOBCT

Lot
Expiry Date

Principal Display Panel (12 Bag Case Label)

Principal Display Panel (12 Bag Case Label)

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