FDA Label Terms Glossary: Contraindication, Description, Dosage, Precautions & More

Key Takeaways

• FDA label terms are standardized phrases that appear on every approved drug label.
• Contraindication tells you when a drug must NOT be used, while Precautions warn about risks that need careful management.
• Description provides the chemical identity and structure of the active ingredient.
• Dosage and Administration gives step‑by‑step dosing instructions for all patient groups.
• Understanding each term helps clinicians read labels faster and improves patient safety.

The FDA’s labeling system can feel like a foreign language, especially when you’re scanning a new prescription. Every label follows a strict template, and each section has a precise legal meaning. This glossary breaks down the most common terms-from Contraindication to the section that warns about serious risks and how to mitigate them-so you know exactly what to look for and why it matters.

What Is an FDA Label Term?

In FDA parlance, a FDA label term is a defined phrase that appears in the prescribed order of a drug’s official label. The label is a legally binding document governed by 21 CFR 314.70 for human drugs and 21 CFR 601.12 for biologics. Each term signals a specific type of information that must be presented in a clear, concise format. The standardization makes it possible for doctors, pharmacists, and patients to find critical safety data quickly, no matter which medication they’re reviewing.

Contraindication

Contraindication is defined by the FDA as "specific situations when the drug should not be used because it may be harmful to the patient." It appears right after the Indications and Usage section and before Warnings and Precautions. There are two flavors:

• Absolute contraindication: use is never recommended (e.g., active pathological bleeding for Xarelto).
• Relative contraindication: use may be considered if benefits outweigh risks (e.g., severe renal impairment for certain NSAIDs).

Regulation 21 CFR 201.57(c)(2) mandates that contraindications be brief, meaningful, and free of trivial risks. The Highlights section of the label must include the most critical contraindications for instant physician visibility.

Description

Description refers to the part of the label that spells out the chemical identity of the active ingredient. This includes the established name, the precise chemical name, and, when applicable, a structural formula that shows stereochemistry. 21 CFR 201.56(b)(2) requires a short summary of the drug substance, so you’ll see entries like "recombinant human IgG1 monoclonal antibody" for Humira (adalimumab) along with its molecular weight and amino‑acid sequence. The section appears both in the Highlights and the Full Label, ensuring that scientists and clinicians alike have access to the exact composition.

Dosage and Administration

Dosage and Administration is the section that tells you how much drug to give, how often, and by which route. It also includes special‑population adjustments for pediatrics, geriatrics, hepatic or renal impairment, and pregnancy. The FDA’s 21 CFR 201.57(d) and 21 CFR 201.56(b)(5) require the information to be presented in a step‑by‑step format that is easy to follow during a time‑pressured clinical encounter.

For example, the Keytruda (pembrolizumab) label lists two dosing regimens: 200 mg every three weeks or 400 mg every six weeks, plus detailed instructions on how to reduce the dose if severe immune‑related adverse events occur. Such clarity helps avoid dosing errors, which accounted for 14.7% of post‑approval label changes in 2023.

Drug Interactions

Drug Interactions are situations where one drug changes the activity of another, a supplement, food, or beverage. The FDA requires clinically significant interactions to be listed under 21 CFR 201.57(f). Studies must evaluate major metabolic pathways-especially CYP enzymes and transporters like P‑gp.

Take apixaban (Eliquis) as an example: its label warns against co‑administration with strong dual inhibitors of CYP3A4 and P‑gp (e.g., ketoconazole) because exposure can rise dramatically, increasing bleeding risk. The guidance released in February 2020 set the standard for how these studies are designed and reported.

Indications and Usage

Indications and Usage is the opening section that defines the disease or condition a drug is approved to treat, along with the patient population. Under 21 CFR 201.56(b)(1), the language must be specific about the disease, the target group, and the treatment goal.

Opdivo (nivolumab) illustrates this well: the label states "treatment of patients with unresectable or metastatic melanoma as a single agent or in combination with ipilimumab." Such precision is required to support the substantial‑evidence standard of 21 CFR 314.126, which demands well‑controlled clinical trials.

Patient Counseling Information

Patient Counseling Information provides clear, actionable advice that clinicians should pass on to patients. It must cover how to take the medication, what side effects to watch for, and storage instructions, per 21 CFR 208.20‑208.26.

The Jardiance (empagliflozin) label, for instance, tells patients to report genital yeast infections, increased thirst, or signs of ketoacidosis immediately. The FDA’s 2021 guidance stresses plain language-no jargon-so patients understand the risk and act quickly.

Precautions (Warnings & Precautions)

Precautions combine the Warnings and Precautions section, highlighting serious adverse reactions and steps to mitigate them. 21 CFR 201.57(c) orders that the most severe risks appear first and are separated clearly from less critical information.

A Boxed Warning-a red‑bordered highlight-appears when there is reasonable evidence of a life‑threatening risk. Trulicity (dulaglutide) carries a boxed warning about thyroid C‑cell tumors, explicitly instructing providers not to use it in patients with a personal or family history of medullary thyroid carcinoma. According to the 2023 CDER report, about 31.7% of novel drug approvals between 2020‑2023 included at least one Boxed Warning.

Regulatory Foundations: 21 CFR 314.70 and Drugs@FDA

All the sections above are anchored in 21 CFR 314.70, the part of the Code of Federal Regulations that spells out the content and format requirements for human drug labeling. The FDA’s Drugs@FDA database hosts the official label for every approved product. Since 2007, labels are submitted in Structured Product Labeling (SPL) XML, enabling searchable, machine‑readable data that feeds clinical decision‑support tools. The 2024 draft guidance on “Enhancing the Utility of Drug Labeling Through Digital Innovation” promises interactive elements in electronic labels by mid‑2025.

Practical Tips for Using the Glossary

• Scan the Highlights first. The top “Highlights” box contains Contraindications, Boxed Warnings, and key Dosage information-perfect for a quick safety check.
• Jump to the section you need. Use the standardized headings (e.g., “Drug Interactions”) to navigate the SPL‑formatted label on Drugs@FDA.
• Cross‑check Patient Counseling. Make sure the advice you give aligns with the label’s counseling section; it’s the most patient‑friendly part of the document.
• Stay updated. Post‑marketing changes (Category 2 updates) happen often; subscribe to the FDA’s label change alerts to keep your knowledge current.

Conclusion

Knowing what each FDA label term means cuts through the jargon and lets you focus on the real clinical takeaways. Whether you’re a prescriber, pharmacist, or a patient looking up a medication, this glossary gives you a reliable map to the most important safety and usage information.