Label: KODATEF- tafenoquine tablet, film coated

  • NDC Code(s): 71475-258-03
  • Packager: 60 Degrees Pharmaceuticals, INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

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Drug Label Information

Updated February 10, 2025

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  • WARNINGS AND PRECAUTIONS
    Hemolytic Anemia - G6PD Deficiency in Pregnancy and Lactation - Methemoglobinemia - Psychiatric Effects - Hypersensitivity Reactions - Delayed Adverse Reactions, Including Hemolytic ...
  • Dear Healthcare Provider Letter
    Dear Healthcare Provider Letter pages 1-61
  • DOSAGE & ADMINISTRATION
    Loading Dose: 200 mg (two of the 100 mg filmcoated tablets) once daily for three days. Maintenance Dose: 200 mg (two of the 100 mg filmcoated tablets) once weekly – start seven days after the ...
  • INDICATIONS & USAGE
    Malaria prophylaxis, consistent with the approved use of ARAKODA
  • PRINCIPAL DISPLAY PANEL
    Kodatef carton label
  • INGREDIENTS AND APPEARANCE
    Product Information
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