Rx Only

Rx Only
SPL v1
SPL
SPL Set ID ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a
Route
INTRAVENOUS
Published
Effective Date 2024-10-28
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tranexamic Acid (1 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-10-28

Description

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Indications and Usage

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.


Medication Information

Indications and Usage

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Description

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Package Label.principal Display Panel

NDC 14593-318-01

Tranexamic Acid Injection, USP

1000 mg/10 mL

(100 mg/mL)

Intravenous Use Only

Rx only

10 mL Single-Dose Vial


Structured Label Content

Indications and Usage (INDICATIONS AND USAGE)

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 14593-318-01

Tranexamic Acid Injection, USP

1000 mg/10 mL

(100 mg/mL)

Intravenous Use Only

Rx only

10 mL Single-Dose Vial


Advanced Ingredient Data


Raw Label Data

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