What is the primary source of drug information that includes FDA approved labeling?

The primary source of drug information that includes FDA-approved labeling is the product package insert. This document, also known as the prescribing information, provides essential details about the medication, including indications, dosage, administration, contraindications, warnings, adverse reactions, and specific populations such as pediatrics or those who are pregnant. Since this information is provided directly from the manufacturer and approved by the FDA, it is considered the most authoritative source for healthcare professionals when seeking information about a specific drug.

In contrast, clinical guidelines synthesize evidence-based recommendations for the management of diseases but do not replace the detailed and specific drug information found in the package insert. Pharmacology textbooks provide broader educational context on drug mechanisms and classifications but do not typically offer up-to-date labeling information. Drug interaction databases may provide valuable insights about potential interactions between medications but lack the comprehensive details found in the product package insert about a single medication’s safety and efficacy.