FDA Label for Tranexamic Acid

View Indications, Usage & Precautions

Tranexamic Acid Product Label

The following document was submitted to the FDA by the labeler of this product Emcure Pharmaceuticals Limited. 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.

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



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


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