FDA-Approved Label
Also known as: drug label, prescribing information, package insert, product label, drug package insert
Verified from FDA Drugs@FDA Glossary on 06-02-2026The FDA-approved label is the regulatory document that defines how a drug product is officially described, including its approved indications, warnings, side effects, and instructions for specific populations. It serves as the primary reference for what the FDA has authorized a manufacturer to communicate about a drug. The verbatim definition from the U.S. Food and Drug Administration follows below.
MedivaScan summary. The authoritative source quote follows below.FDA Drugs@FDA Glossary definition
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.