How to read Highlights of Prescribing Information: the half-page front of an FDA label, line by line

What this guide covers (and how it differs from sister pages)

Our hub guide, How to read FDA peptide labeling, explains the overall PLR layout (Highlights, Table of Contents, Full Prescribing Information) in a few sentences. Over the past weeks we have published deep dives on most of the numbered Full PI sections: Indications and Usage (Section 1), Dosage Forms and Strengths (3), Warnings and Precautions and Adverse Reactions (5–6), Drug Interactions (7), Use in Specific Populations (8), Drug Abuse and Dependence (9), Overdosage (10), Description (11), Clinical Pharmacology (12), Nonclinical Toxicology (13), Clinical Studies (14), How Supplied (16) and Patient Counseling (17).

This Day 47 guide is the companion for the front matter itself. It covers what the regulation requires Highlights to contain, how FDA's guidance says each part should be written, and what each line can and cannot tell a reader. We quote current GLP-1 labels from DailyMed only to show structure and wording. This page reproduces no doses, titration steps or strengths, and nothing here suggests who should or should not use any medicine.

Where Highlights comes from: the Physician Labeling Rule

In January 2006 FDA published the final rule "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products" (71 FR 3922), commonly called the Physician Labeling Rule. It reorganized prescription labeling into three parts:

• Highlights of Prescribing Information: a concise summary, limited to about half a page (not counting any Boxed Warning).
• Full Prescribing Information: Contents: a table of contents for the numbered sections.
• Full Prescribing Information (FPI): the numbered sections 1–17, where the details, evidence and qualifications live.

The 15 required elements, in order

21 CFR 201.57(a) lists what Highlights must contain, and 201.56(d)(1) fixes the order of the headings. In reading order:

• Title: "HIGHLIGHTS OF PRESCRIBING INFORMATION" (201.56(d)(1)).
• Highlights limitation statement (verbatim, bold) (201.57(a)(1)).
• Product title line: proprietary name, established name, dosage form, route, and controlled-substance symbol if any (a)(2).
• Initial U.S. Approval with a four-digit year (a)(3).
• Boxed Warning summary, if the FPI has a boxed warning (a)(4).
• Recent Major Changes, if any qualifying change was made in the past year (a)(5).
• Indications and Usage (a)(6).
• Dosage and Administration (a)(7).
• Dosage Forms and Strengths (a)(8).
• Contraindications, or the word "None" (a)(9).
• Warnings and Precautions (a)(10).
• Adverse Reactions, plus the verbatim reporting statement (a)(11).
• Drug Interactions (a)(12), only if clinically significant interactions exist.
• Use in Specific Populations (a)(13), only if there are clinically important differences.
• Patient Counseling Information statement (a)(14), then the Revision date (a)(15).

The limitation statement: the label's own disclaimer

The first bold sentence is fixed by 201.57(a)(1):

"These highlights do not include all the information needed to use (insert name of drug product) safely and effectively. See full prescribing information for (insert name of drug product)."

The current Ozempic label reads: "These highlights do not include all the information needed to use OZEMPIC® safely and effectively. See full prescribing information for OZEMPIC." FDA's guidance recommends the product name in upper case for prominence.

This sentence is the single most useful reading instruction on the page. Highlights is selective by design, and the regulation makes the label say so. A screenshot of Highlights, a pharmacy handout that reproduces only Highlights, or an AI summary built from Highlights alone is, by the label's own admission, missing information needed for safe use.

The title line and "Initial U.S. Approval"

Title line. Under 201.57(a)(2), the bold product title gives the proprietary name and the established name (or, for biologics, the proper name), followed by the dosage form and route of administration. Examples from current DailyMed labels:

• "OZEMPIC (semaglutide) injection, for subcutaneous use"
• "WEGOVY (semaglutide) injection, for subcutaneous use" followed by a second line, "WEGOVY (semaglutide) tablets, for oral use." One label can cover more than one dosage form, and each gets its own title line.
• "MOUNJARO® (tirzepatide) Injection, for subcutaneous use"
• "QSYMIA (phentermine and topiramate extended-release capsules), for oral use, CIV." For a controlled substance, the DEA schedule symbol goes at the end of the line (our Day 46 guide explains Section 9 and the CII–CV symbols).

The Boxed Warning in Highlights

If the FPI contains a Boxed Warning, 201.57(a)(4) requires Highlights to carry "a concise summary," "not to exceed a length of 20 lines." It must be inside a box, in bold, under an upper-case heading containing the word "WARNING," and immediately followed by the verbatim sentence "See full prescribing information for complete boxed warning."

FDA's guidance and the SRPI format checklist that FDA reviewers use add several conventions:

• The word is "WARNING," never "WARNINGS," even when the box covers several topics. Topics are joined by a lower-case "and" (e.g., "WARNING: SERIOUS INFECTIONS and ACUTE HEPATIC FAILURE").
• There is one box in the FPI and one summarized box in Highlights. Nothing may appear in the Highlights box that is not in the FPI box.
• Bullets are recommended, each one a discrete warning, and each carries section cross-references.

Recent Major Changes: the label's change log

Recent Major Changes (RMC) is the part of Highlights that tells you what has changed lately. The rules in 201.57(a)(5) and FDA's guidance are specific:

• Only five sections qualify: Boxed Warning, Indications and Usage, Dosage and Administration, Contraindications, and Warnings and Precautions. Changes to Adverse Reactions, Drug Interactions, Clinical Studies and other sections are never listed here, even when they are important.
• Only substantive changes. FDA's guidance excludes typo and grammar fixes, and changes that come only from converting to PLR format.
• Each entry gives the section heading, the subsection heading if appropriate, the section number and the month/year the change was incorporated (for prior-approval changes, the supplement approval date). Example from FDA's guidance: "Indications and Usage, Hypertension (1.2) 6/2011."
• Order follows the FPI, not the calendar. If space is short, only the main section heading and the latest date may be listed.
• Duration: an entry stays at least one year and must be removed at the first printing after that year.
• Vertical bar: under 201.57(d)(9), the corresponding new or modified text in the FPI is marked with a vertical line on its left edge. On DailyMed and in PDFs, that bar is how you find exactly what changed.
• Deletions: FDA's guidance says removals should be identified too. Current DailyMed labels show this in practice: the Wegovy, Saxenda and Zepbound RMC lists each include "Suicidal Behavior and Ideation … (Removed) 02/2026."

The middle of Highlights: concise summaries with section pointers

The middle of Highlights summarizes the corresponding FPI sections. Each one has its own GLPWiki deep dive, so here we focus only on how the Highlights version differs.

• Indications and Usage. Must name the established pharmacologic class when one exists, in the form "(Drug) is a (name of class) indicated for (indication(s))" (201.57(a)(6)). FDA's 2009 guidance on Established Pharmacologic Class defines how the class term is chosen. That is why the Ozempic Highlights begins "OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated:" and Zepbound's begins "ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated…". Major limitations of use must be briefly noted. See our Indications and Usage guide.
• Dosage and Administration, and Dosage Forms and Strengths. Concise summaries of Sections 2 and 3. FDA's guidance allows a pointer to the FPI when the regimen is too complex to summarize, and keeps appearance descriptors (color, shape, imprint) out of Highlights. GLPWiki does not reproduce dosing; see our Dosage Forms and Strengths guide for how strengths are written.
• Contraindications. Must list every contraindication in the FPI, or the word "None." This is one of the few Highlights headings meant to be complete.
• Warnings and Precautions. Only "the most clinically significant" items. FDA's guidance asks each bullet to name the risk, its consequence and the action to prevent or reduce it, and to avoid vague phrases like "use with caution." Not every Section 5 subsection appears.
• Adverse Reactions. The most common reactions, with the inclusion threshold stated (for example "≥5%"), followed by the bold reporting sentence: "To report SUSPECTED ADVERSE REACTIONS, contact [manufacturer] at [phone] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch." Vaccines point to VAERS instead. This line is the label's built-in route to MedWatch.
• Drug Interactions and Use in Specific Populations. Each heading appears only when there is something clinically significant to summarize. FDA's guidance says the absence of data in a population should ordinarily not be listed, and that a risk already summarized elsewhere in Highlights should not be repeated. For example, the Ozempic Highlights has a single Drug Interactions bullet about delayed gastric emptying and oral medications (7.2).

The last two lines: patient labeling pointer and revision date

Patient Counseling statement. Under 201.57(a)(14), Highlights ends with "See 17 for PATIENT COUNSELING INFORMATION," extended to "…and Medication Guide" or "…and FDA-approved patient labeling" when those exist. FDA's guidance says a product with both a Medication Guide and Instructions for Use refers only to the Medication Guide. The current Ozempic and Zepbound Highlights end "See 17 for PATIENT COUNSELING INFORMATION and Medication Guide." This line tells you a patient-facing document exists; our Patient Counseling and Medication Guide guide explains how to read it.

Revision date. Under 201.57(a)(15), the date of the most recent labeling revision closes Highlights, preferably "Revised: Month/Year." FDA's guidance notes that "FDA-approved patient labeling or Medication Guides can have revision dates that differ from the revision date at the end of Highlights." On DailyMed you will often see several "Revised:" dates on one page. The Ozempic page we checked shows "Revised: 5/2026" at the end of Highlights, while its patient documents carry different dates.

Keep four dates apart (Figure 2):

• Initial U.S. Approval: the year the molecule or combination was first approved. It never changes.
• Recent Major Changes dates: when specific changes to those five sections were incorporated.
• "Revised:" at the end of Highlights: the latest revision of the Prescribing Information.
• DailyMed version or "published" date: when that SPL version was posted to DailyMed. It can lag or differ from the Revised date. Drugs@FDA labels are tied to specific approval actions; DailyMed shows the version the company currently has in use.

Common misreadings, and what Highlights cannot tell you

• "It's not in Highlights, so it's not a risk." Highlights is capped at half a page (a waiver is possible under 21 CFR 201.58), and FDA's guidance tells applicants to list each risk once, under the most appropriate heading. A drug interaction summarized under Warnings and Precautions, for example, is not repeated under Drug Interactions. Check the FPI.
• "Initial U.S. Approval 2017 means this product was approved in 2017." It dates the active molecule (Section 5 above).
• "No Recent Major Changes means the label hasn't changed." RMC covers only five sections and one year.
• "Highlights is the patient summary." Highlights is written for prescribers. The patient-facing documents are the Medication Guide, Patient Information and Instructions for Use, pointed to by the "See 17" line.
• "A Highlights from one product applies to another product with the same molecule." Each label covers the products, forms and routes named on its title line. Highlights from an approved brand does not describe a compounded or "research" product, which has no FDA-approved label at all (see our compounded vs FDA-approved guide).
• "The bullets are complete sentences of fact." They are summaries with qualifiers removed. The Ozempic boxed-warning example in Section 6 shows how much context lives only in the FPI.

A five-step way to read any Highlights

• Confirm the product. Read the title line (brand, established name, form, route, any schedule symbol) and make sure it matches the product you are asking about.
• Read the limitation statement as an instruction. Highlights is a map, not the territory.
• Check the box and the change log. Note any Boxed Warning heading, then scan Recent Major Changes and look for the vertical bars in the FPI.
• Follow every number in parentheses. Read the FPI section behind any bullet that matters to your question.
• Note the dates and the source. Record the "Revised:" date and where you read the label (Drugs@FDA, DailyMed or FDALabel), so you know which version you are citing.

Scope and disclaimer

GLPWiki is an educational resource. This guide explains how FDA prescription drug labeling is structured; it is not medical advice, does not provide dosing information, and does not recommend any treatment. Label contents change; always check the current FDA-approved labeling and talk with a licensed clinician or pharmacist about any medicine. To report a suspected adverse reaction, contact the manufacturer or FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. Last reviewed 2026-10-26.

Last reviewed: October 26, 2026. Labeling and guidance may have changed since; verify with Drugs@FDA, DailyMed, and your pharmacist or clinician.