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.
Tranexamic Acid Injection, Solution
FDA Label NDC 14593-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Emcure Pharmaceuticals Limited for the product Tranexamic Acid (NDC 14593-318). 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 indications and usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label (996040a7 8eaa 4dcc Ba36 5c37d4db8113 01)
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