Label: OSELTAMIVIR PHOSPHATE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 7, 2025

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Influenza - Oseltamivir Phosphate Capsules, USP are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage and Administration Overview - Administer oseltamivir phosphate capsules for the treatment of influenza in patients 2 weeks of age or older [ see - Dosage and Administration ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Oseltamivir Phosphate Capsules: 30-mg capsules (30 mg free base equivalent of the phosphate salt): White Opaque/White Opaque Capsule, imprinted with black ink "N" on the body and black ink ...
  • 4 CONTRAINDICATIONS
    Oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Skin/Hypersensitivity Reactions - Cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed below and elsewhere in the labeling: Serious skin and hypersensitivity reactions [ see - Warnings and Precautions (5.1) ...
  • 7 DRUG INTERACTIONS
    7.1 Influenza Vaccines - Live Attenuated Influenza Vaccine - The concurrent use of oseltamivir phosphate capsules with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies with oseltamivir phosphate capsules in pregnant women to inform a drug-associated risk of  adverse developmental ...
  • 10 OVERDOSAGE
    Reports of overdoses with oseltamivir phosphate capsules have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse ...
  • 11 DESCRIPTION
    Oseltamivir Phosphate Capsules, USP, an influenza neuraminidase inhibitor (NAI), are available as capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Oseltamivir is an antiviral drug with activity against influenza virus - [see - Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption and ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In 2-year carcinogenicity studies in mice and rats given daily oral doses of the prodrug oseltamivir phosphate up to 400 mg/kg and 500 ...
  • 14 CLINICAL STUDIES
    14.1 Treatment of Influenza - Adults - Two randomized, placebo-controlled double-blind clinical trials of oseltamivir phosphate capsules were conducted in adults between 18 and 65 years old, one ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Oseltamivir Phosphate Capsules, USP - 30-mg capsules (30 mg free base equivalent of the phosphate salt): Hard Gelatin, White Opaque/White Opaque Capsule, imprinted with black ink "N" on the body ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Serious Skin/Hypersensitivity Reactions - Advise patients and/or caregivers of the ...
  • SPL PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Oseltamivir (oh'' sel tam' i vir) Phosphate Capsules USP, for oral use - What are Oseltamivir Phosphate Capsules? Oseltamivir phosphate capsules are a ...
  • INSTRUCTIONS FOR USE SECTION
    INSTRUCTIONS FOR USE - Oseltamivir (oh'' sel tam' i vir) Phosphate Capsules USP, for oral use - How do I mix the contents of oseltamivir phosphate capsules with sweetened liquids, if ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 70710-1008-2 - OSELTAMIVIR PHOSPHATE Capsules, USP - 30* mg - *Each capsule contains oseltamivir phosphate equivalent to 30 mg oseltamivir (free base). Zydus Pharmaceuticals - 10 Capsules - (1 x 10 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 70710-1009-2 - OSELTAMIVIR PHOSPHATE Capsules, USP - 45* mg - *Each capsule contains oseltamivir phosphate equivalent to 45 mg oseltamivir (free base). Zydus Pharmaceuticals - 10 Capsules - (1 x 10 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 70710-1010-2 - OSELTAMIVIR PHOSPHATE Capsules, USP - 75* mg - *Each capsule contains oseltamivir phosphate equivalent to 75 mg oseltamivir (free base). Zydus Pharmaceuticals - 10 Capsules - (1 x 10 ...
  • INGREDIENTS AND APPEARANCE
    Product Information