Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Oncology Center of Excellence

Oncology Center of Excellence

                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community Home
          About FDA
          FDA Organization
          Oncology Center of Excellence
          How Do I Use Prescription Drug LabelingOncology Center of Excellence How Do I Use Prescription Drug Labeling
  
  	
    Share
    Post
    Linkedin

    Email
    Print*Please watch this short video to learn more about FDA product labeling*



Overview

The USPI is divided into Highlights of Prescribing Information, Table of Contents, and the Full Prescribing Information (FPI); and is often followed by Patient Information. If the product has a Medication Guide, it is provided as a separate document. Each part of the USPI follows a structured format to provide consistent relevant drug information to healthcare providers.

Prescription Drug Labeling
Jump to:

Highlights of Prescribing Information
	Section 1: Indications and Usage
	Section 2: Dosage and Administration
	Section 3: Dosage Forms and Strengths
	Section 4: Contraindications
	Section 5: Warnings and Precautions
	Section 6: Adverse Reactions
	Section 7: Drug Interactions
	Section 8: Use in Specific Populations
	Section 9: Drug Abuse and Dependence
	Section 10: Overdosage
	Section 11: Description
	Section 12: Clinical Pharmacology
	Section 13: Nonclinical Toxicology
	Section 14: Clinical Studies
	Section 15: References
	Section 16: How Supplied/Storage and Handling
	Section 17: Patient Counseling InformationPrescribing Information

Highlights of Prescribing Information

Highlights of Prescribing Information

Many of the most important aspects of a drug can be quickly identified by reading the Highlights of Prescribing Information (Highlights), the first part of the Prescribing Information, which contains a concise and informative summary of crucial prescribing information; however, as this is a summary, it should not be used as a stand-alone document. Specific information in Highlights corresponds (and if provided electronically, may be hyperlinked) to more detailed information in the Full Prescribing Information (FPI).

Full Prescribing Information: Contents (Table of Contents)

The Table of Contents lists the sections and subsections of the FPI.

Full Prescribing Information

Section 1: Indications and Usage

Indications and Usage

Clearly communicates information on the FDA-approved indications that are supported by substantial evidence of safety and effectiveness.

Section 2: Dosage and Administration

Dosage and Administration

Provides the recommended dose, including the dosage range, dosing interval, usual duration, dosage modifications due to adverse reactions, recommended dosage in patients with renal or hepatic impairment if different from the dose from those with normal organ function, recommended dosage in patients taking other drugs with the potential for clinically important interactions, and instructions on how to safely prepare and administer the drug. For oncology drug products, this section may also provide information on tests to be performed prior to administration (e.g., companion or complementary diagnostic tests), premedications or concomitant medications required to ensure safe use, and a reference to information for special handling and disposal of cytotoxic drugs.

Section 3: Dosage Forms and Strengths

Dosage Forms and Strengths

Provides information on the available dosage forms and strengths with a description of identifying characteristics such as shape, color, coating, scoring, and imprinting (when applicable).

Section 4: Contraindications

Contraindications

Identifies the clinical situations for which specific concomitant diseases or conditions or prior medical history poses a risk that clearly outweighs any potential benefit of the drug. Such contraindications consider the seriousness of the underlying disease and the availability of alternative therapy.

Section 5: Warnings and Precautions

Warnings and Precautions

Identifies and provides information on the most serious and clinically significant adverse reactions and other potential safety hazards. Detailed adverse reaction information (e.g., frequency and severity), discontinuation criteria, and recommendations to identify, manage or prevent these adverse reactions are generally provided.

Section 6: Adverse Reactions

Adverse Reactions

Identifies adverse reactions (defined as undesirable effects reasonably associated with use of a drug) identified in clinical trials and postmarketing experience. The listing of common adverse reactions that are important for patient management decisions are typically provided in a tabular format. This section typically identifies the most common serious (including fatal) adverse reactions and the most frequent adverse reactions requiring dose interruption, reduction or discontinuation.

Section 7: Drug Interactions

Drug Interactions

Describes clinically important interactions which may lead to an increased frequency or severity of an adverse reaction or decrease the effectiveness of a drug, and practical instructions to mitigate the risks of these interactions.

Section 8: Use In Specific Populations

Use In Specific Populations

Includes important information related to administration of a drug during pregnancy and lactation, known effects on fertility, and available information about the pharmacokinetics, safety or effectiveness in pediatric or geriatric patients or those with renal and hepatic impairment. With implementation of the FDA Pregnancy and Lactation Labeling Rule, the information in this section is now standardized to ensure consistent content and format.

Section 9: Drug Abuse and Dependency

Drug Abuse and Dependency

Conveys information about a drug’s potential for abuse, misuse, addiction, physical dependence, and tolerance to inform prescribing decisions for safe and effective use. This section is generally inapplicable and omitted from the labeling for oncology drug products; however, this section may be important for other drugs used to palliate cancer-related symptoms (e.g., pain) or manage adverse reactions associated with an oncology drug product (e.g., nausea/vomiting).

Section 10: Overdosage

Overdosage

Provides human data (or laboratory or animal data) that describe the signs, symptoms and laboratory abnormalities occurring with drug overdosage, as well as recommendations on overdosage treatment. When no clinically meaningful information is available, this section may be omitted.

Section 11: Description

Description

Includes the established pharmacological class, chemical name, structural formula, dosage form, route of administration, active and inactive ingredients, and other important physical or chemical information to assure safe use.

Section 12: Clinical Pharmacology

Clinical Pharmacology

Details the mechanism of action, pharmacodynamic, and pharmacokinetic aspects essential to understanding dosing or information presented in other sections of the USPI.

Section 13: Nonclinical Toxicology

Nonclinical Toxicology

Provides detailed information on carcinogenesis, mutagenesis, impairment of fertility and adverse events observed in animal studies that are important to understand clinical adverse reactions.

Section 14: Clinical Studies

Clinical Studies

This section provides a summary of the studies conducted to establish safe and effective use, including study design, patient selection criteria, a description of the population studied (e.g., patient and disease characteristics), and efficacy outcomes If applicable to healthcare providers making treatment decisions, relevant information on the outcomes in subpopulations are also summarized in this section.

Section 15: References

References

For cytotoxic drugs, references to safe handling information are listed in this section.

Section 16: How Supplied/Storage and Handling

How Supplied/Storage and Handling

Provides information on the dosage forms, strengths, NDC numbers, package quantities, and storage and handling conditions.

Section 17: Patient Counseling Information

Patient Counseling Information

The last section of the USPI identifies the important aspects of the drug that a healthcare provider should convey to a patient or caregiver when a counseling discussion is taking place. This section references FDAapproved patient labeling if available.

FDA-Approved Patient Labeling

Patient labeling may be physically attached or provided separately from the USPI and contains information in lay language that can help patients use a drug safely and effectively. Types of FDA-approved patient labeling include Patient Package Inserts (PPIs), Medication Guides (MGs), and Instructions for Use (IFUs). A Medication Guide must be provided to the patient whenever the drug is dispensed. FDA-approved patient labeling is important to help patients mitigate and avoid serious adverse reactions or medication errors.

Additional Information

Project Renewal Home
	Project Renewal FAQ
	About Product Labeling
	FDA Oncology Center of Excellence Home
	FDA's Labeling Resources for Human Prescription Drugs

                                                                                  Content current as of:
      03/29/2023Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop