Paroxetine Tablet, Film Coated
FDA Label NDC 61919-513

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Direct Rx for the product Paroxetine (NDC 61919-513). 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 description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, adverse reactions ii, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.