Guidance for Industry 

 
Labeling for Human Prescription 

Drug and Biological Products  

Implementing the PLR Content and 

Format Requirements 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 

 
February 2013 

Labeling 

 
 
   
 
 
Guidance for Industry 
 
 
Labeling for Human Prescription 

Drug and Biological Products  

Implementing the PLR Content and 

Format Requirements 

 
 
 
 
Additional copies are available from: 

 
Office of Communications 
 
Division of  Drug Information, WO51, Room  2201 
 
10903 New Hampshire Ave. 

Silver Spring, MD   20993 
  
Phone: 301-796-3400;  Fax: 301-847-8714 
 
druginfo@fda.hhs.gov 
  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
or 

Office of Communication, Outreach  and  

Development, HFM-40 
 
Center for Biologics Evaluation and Research 

 Food and Drug  Administration 

1401 Rockville Pike, Rockville, MD   20852-1448  

ocod@fda.hhs.gov 

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
(Tel)  800-835-4709 or 301-827-1800  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
February 2013 
Labeling 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
I.   INTRODUCTION............................................................................................................. 1 
 
II.   BACKGROUND ............................................................................................................... 2 
 
III.   CONSIDERATIONS FOR REVISING LABELING.................................................... 2 
 
A.   Developing New Sections...............................................................................................................3
  
B.   Data Analyses or New Studies ......................................................................................................3
  
C.   Updating Information in Labeling...............................................................................................4
  
IV.   DISTRIBUTING INFORMATION AMONG SECTIONS .......................................... 4 
 
A.   Organizing Information to Avoid Redundancy ..........................................................................4 
 
B.   Using Cross-References.................................................................................................................5
  
C.   Example of the Distribution of Information Among Labeling Sections ...................................5
  
V.   HIGHLIGHTS .................................................................................................................. 6 
 
A.   General Principles..........................................................................................................................6
  
B.   Information in Highlights..............................................................................................................7
  
1. 	  Highlights Title and Limitation Statement ( 201.56(d)(1) and 201.57(a)(1)) .......................7
  
2. 	  Product Title: Drug Names, Dosage Form, Route of Administration, and Controlled 

Substance Symbol ( 201.57(a)(2))...........................................................................................7 
 
3. 	  Initial U.S. Approval ( 201.57(a)(3)).......................................................................................7
  
4. 	  Boxed Warning ( 201.57(a)(4)) ...............................................................................................7
  
5. 	  Recent Major Changes ( 201.57(a)(5)) ...................................................................................8
  
6. 	  Indications and Usage ( 201.57(a)(6))..................................................................................11
  
7. 	  Dosage and Administration ( 201.57(a)(7))..........................................................................11 
 
8. 	  Dosage Forms and Strengths ( 201.57(a)(8)) .......................................................................12 
 
9. 	  Contraindications ( 201.57(a)(9)).........................................................................................12
  
10.  Warnings and Precautions ( 201.57(a)(10)).........................................................................13 
 
11.  Adverse Reactions ( 201.57(a)(11)) ......................................................................................13
  
12.  Drug Interactions ( 201.57(a)(12)) .......................................................................................15
  
13.  Use in Specific Populations ( 201.57(a)(13))........................................................................15
  
14.  Patient Counseling Information Statement ( 201.57(a)(14)).................................................16
  
15.  Revision Date ( 201.57(a)(15)) .............................................................................................16 
 
VI.   FORMATTING............................................................................................................... 17 
 
A.   Subsection Headings ....................................................................................................................17
  
B.   Omitted Sections ( 201.56(d)(4))...............................................................................................18
  
C.   Cross-References..........................................................................................................................18
  
D.   Type Size and Font Type.............................................................................................................18
  
E.   Use of Abbreviations....................................................................................................................19
  
VII.   PROCEDURAL INFORMATION................................................................................ 19 
 
A.   Applications Covered by the Final Rule....................................................................................19
  
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  Contains Nonbinding Recommendations  
 
 
1.   New NDAs, BLAs, and Efficacy Supplements .........................................................................19
  
2.   Approved Applications............................................................................................................20
  
3.   Submitting Draft Labeling to FDA for Review........................................................................20
  
B.   Changes to the Regulations for Applications Not Covered by the Final Rule .......................21
  
C.   Appending FDA-Approved Patient Labeling............................................................................21 
 
D.   Submitting Electronic Versions of Labeling..............................................................................22 
 
E.   Waivers and CBE Supplements..................................................................................................22
  
F.   Class Labeling ..............................................................................................................................23 
 
1.   Mandated Statements ..............................................................................................................23
  
2.   Class Labeling Statements That Are Not Mandated by Regulation ........................................23
  
G.   Abbreviated New Drug Application (ANDA) Products ...........................................................24
  
H.   505(b)(2) NDA Products ..............................................................................................................24
  
I.   Manufacturer Information .........................................................................................................24
  
VIII.   ADDITIONAL LABELING GUIDANCES ................................................................. 25 
 
APPENDIX A  IMPLEMENTATION PLAN...................................................................... 26 
 
APPENDIX B  PRESCRIPTION DRUG LABELING SECTIONS.................................. 27 
 
APPENDIX C  REORGANIZING LABELING SECTIONS ............................................ 28 
 
APPENDIX D  TYPE SIZE REQUIREMENTS FOR LABELING AND FDA-
APPROVED PATIENT LABELING INCLUDED WITH LABELING............................... 29 
 
APPENDIX E HIGHLIGHTS AND CONTENTS FORMAT SAMPLE.......................... 30 
 
 
 
  ii  Contains Nonbinding Recommendations 
 
Guidance for Industry1  
 
Labeling for Human Prescription Drug and Biological Products2  

Implementing the PLR Content and Format Requirements3
  
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any  person and does not operate to bind FDA or the public.  
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations. If you want to  discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance. 
 
 
 
 
I.   INTRODUCTION 
 
This guidance is intended to assist applicants in complying with the content and format 
requirements of labeling for human prescription drug and biological products under 21 CFR 
201.56(d) and 201.57. FDA is issuing this guidance to provide recommendations for applicants 
developing labeling for new prescription drugs and revising labeling for already approved 
prescription drugs. This guidance also provides recommendations on developing Highlights of 
Prescribing Information (Highlights), formatting labeling, and procedural information.  
   
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
                                                 
1  This guidance has been prepared by the Office of Medical  Policy in the Center for Drug  Evaluation and Research 
 
(CDER) and Center  for Biologics Evaluation and Research (CBER) at the Food and Drug  Administration.  

2 This  guidance applies to  drugs, including biological drug  products.  For the purposes of this  guidance,  drug or  drug 
 
product will be used to refer to  human prescription  drug and  human prescription  biological products that are 

regulated as drugs. 

3 See the final rule Requirements  on Content  and Format of Labeling for Human Prescription Drug and Biological
  
Products, 71 FR 3922, January 24, 2006.  This rule is commonly referred to as the Physician Labeling  Rule (PLR) 
 
because it addresses prescription drug labeling that is used  by prescribers and other health care professionals.  
 
 
1 

  Contains Nonbinding Recommendations  
 
 
 
II.  BACKGROUND   

 
On January 24, 2006, FDA published a final rule that amended the requirements for the content 
and format of labeling for human prescription drug and biological products.  The rule is 
commonly referred to as the Physician Labeling Rule (PLR) because it addresses prescription 
drug labeling that is used by prescribers and other health care practitioners.  The rule was 
designed to make information in prescription drug labeling easier for health care practitioners to 
access, read, and use to facilitate practitioners use of labeling to make prescribing decisions.  
Labeling includes three sections: Highlights of Prescribing Information (Highlights), a Table of 
Contents (Contents), and the Full Prescribing Information (FPI). Highlights contains selected 
information from the FPI that health care practitioners most commonly reference and consider 
most important.  Contents lists the sections and subsections of the FPI.  FPI contains the detailed 
prescribing information necessary for safe and effective use of the drug.  The final rule also 
reordered and reorganized the FPI, made minor changes to the content of the FPI, and set 
minimum graphic requirements for the format of the labeling.   
 
Not all drugs are subject to the labeling requirements under  201.56(d) and 201.57.  The final 
rule is being implemented on a staged implementation schedule that, based on approval date or 
application status, requires new and recently approved prescription drugs to comply with these 
labeling requirements by a particular date (see  201.56(b) and Appendix A).  Prescription drugs 
that are not subject to  201.56(d) and 201.57 are subject to the labeling requirements under  
201.56(e) and 201.80. The final rule also made minor changes to these regulations.   
 
For the purpose of this guidance, the term  PLR format refers to labeling that meets the content 
and format requirements at  201.56(d) and 201.57.  The term old format refers to labeling that 
meets the requirements at  201.56(e) and 201.80.  See Appendix B for a listing of prescription 
drug labeling sections in the old and PLR formats.   
 
In general, the most challenging aspects of this regulation are developing Highlights and 
distributing information among sections that have been substantially affected by the rule, 
particularly when the information originates from the labeling in the old format.  Therefore, the 
guidance focuses primarily on these issues.  Additional guidance documents that address content 
and format for specific FPI sections are available and should be consulted when developing 
labeling (see section VIII of this document). 
 
III.  CONSIDERATIONS FOR REVISING LABELING 
   
The FPI in the PLR format contains substantially the same information as labeling in the old 
format, typically with reordering and reorganization of the information.  For example, new 
labeling sections (e.g., DRUG INTERACTIONS, USE IN SPECIFIC POPULATIONS, 
PATIENT COUNSELING INFORMATION) contain information formerly included in the 
PRECAUTIONS section.  Certain sections (e.g., CLINICAL STUDIES, NONCLINICAL 
TOXICOLOGY) that were previously optional are now required if applicable ( 201.56(d)).  
Therefore, although labeling in the old format for approved products does not contain the new 
section headings, most of the content already is included in the labeling under different headings 
 
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  Contains Nonbinding Recommendations  
 
 
or subheadings. For example, information from the old WARNINGS section and old 
PRECAUTIONS section is consolidated into a single new section (WARNINGS AND 
PRECAUTIONS) and information in certain old PRECAUTIONS subsections (e.g., Information 
for Patients, Drug Interactions, Pregnancy, Labor and Delivery, Nursing Mothers, Pediatric 
Use, Geriatric Use) is relocated to new labeling sections (e.g., PATIENT COUNSELING 
INFORMATION, DRUG INTERACTIONS, USE IN SPECIFIC POPULATIONS).  
 
Making the transition to the PLR format provides an ideal opportunity to review the labeling 
content for general quality (e.g. format, organization, and readability) and to make it a better 
communication tool.   FDA recommends following these general principles when converting 
labeling in the old format to the PLR format. 
 
A.  Developing New Sections 
 
FDA expects that most sections or subsections from labeling in the old format can be moved, 
with little or no modification, to corresponding sections in the PLR format (see Appendix C).  
However, the labeling in the old format may not include the information specified by the new 
regulations, or the content of a section may not adequately reflect scientific information needed 
for safe and effective use of the drug. In this case, the labeling must be updated ( 201.56(a)).    
 
If the labeling in the old format lacks an entire section that is required in the PLR format, the 
section must be developed unless it is clearly inapplicable ( 201.56(d)).  For example, if the 
labeling in the old format does not contain an Information for Patients subsection in the 
PRECAUTIONS section, the applicant must develop a PATIENT COUNSELING 
INFORMATION section because, with only limited exceptions, there will be important 
information about a drug for the prescriber to convey to the patient or caregiver.  In another 
example, it may not be necessary to develop a CLINICAL STUDIES section for certain older 
products (e.g., when data are not readily available).    
 
B.  Data Analyses or New Studies 
 
FDA recognizes that revising labeling to comply with the PLR regulations is an excellent 
opportunity to update labeling content to ensure that it accurately reflects current knowledge.  
FDA expects that, in most cases, the revisions will involve limited rewriting aimed at clarifying 
text, eliminating redundancies, and updating outdated terminology.  Generally, no new data 
analyses of the information in the old format are required if the labeling is truthful and accurate.  
However, if new information is available that  causes the labeling to be inaccurate, the labeling 
must be updated to incorporate the new information ( 201.56(a)(2)).  In some cases, a re-
analysis of the data may be necessary.   
 
Furthermore, if essential information is missing from the labeling (e.g., new information about a 
class drug interaction), this information must be included ( 201.56(a)(2)).  In this case, the 
review division would determine the need for a new study, a decision that would be made 
independent of the labeling conversion process. 
   
 
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  Contains Nonbinding Recommendations  
 
 
C.  Updating Information in Labeling 
 
By regulation, all express or implied claims  in labeling must be supported by substantial 
evidence.4  If unsubstantiated claims currently exist in labeling, the applicant must revise the 
labeling to remove such claims ( 201.56(a)(3)).  Although the content of labeling in the old 
format will not substantially change when converted to PLR format, the applicant should 
systematically evaluate information in labeling to identify unsubstantiated claims or outdated 
information and revise it accordingly.    
 
Revisions to the content requirements in certain sections may result in the need to review and 
revise those sections. For example, consider the ADVERSE REACTIONS section.  For the 
purposes of prescription drug labeling, the definition of adverse reaction in  201.57(c)(7) was 
revised to clarify that it does not include all adverse events observed during use of a drug, only 
those adverse events for which there is some  basis to believe there is a causal relationship 
between the drug and the occurrence of the adverse event.  When updating labeling, the applicant 
should review the ADVERSE REACTIONS section to ensure all events appropriately fall under 
that section and delete those events unlikely to have been caused by the drug (i.e., usually a 
lengthy listing commonly referred to as the laundry list). Because such a list is not essential to 
the safe and effective use of the drug, it should simply be omitted.   
 
The OVERDOSAGE section is another example of a labeling section that is typically not 
revisited after initial approval.  However, postmarket experience with overdose may inform new 
management recommendations for the drug product and the labeling content should be updated 
to reflect current knowledge. 
 
IV.  DISTRIBUTING INFORMATION AMONG SECTIONS 
 
When creating labeling in PLR format or converting labeling in the old format to the PLR 
format, applicants face many decisions about how to distribute information among labeling 
sections. Often sections or subsections can be moved with little or no modification (see 
Appendix C). In some cases, it will be more appropriate to move certain information from a 
labeling section in the old format to a different labeling section in the PLR format or to 
consolidate similar issues in one place.  In other cases, it will be appropriate to divide portions of 
information in a single labeling section among two or more sections.  The following general 
principles and examples are offered to help applicants make decisions about how to organize 
information.  These considerations apply whether revising labeling from the old format or 
creating new labeling. 
 
A.  Organizing Information to Avoid Redundancy  
 
Clinical information pertinent to prescribing decisions should be identified, prioritized, and 
located in the labeling section that most appropriately communicates the type of information.  
Detailed information about a particular topic should be consolidated in a single labeling section.  
                                                 
4 See   201.56(a)(3).  See also   201.57(c)(2)(iii), (c)(2)(iv), (c)(2)(v), (c)(7)(iii), and (c)(15)(i), and  
201.80(c)(2)(i), (c)(2)(ii), (g)(4), and (m)(1)(i).  
 
 
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  Contains Nonbinding Recommendations  
 
 
Other sections of labeling may more briefly describe or refer to the topic, but not repeat the same  
content or level of detail. For example, information about a drug interaction that rises to the 
level of a warning will be described in the WARNINGS AND PRECAUTIONS section, with 
supporting detail in the DRUG INTERACTIONS section and other sections as appropriate (e.g., 
DOSAGE AND ADMINISTRATION section if a dosage modification is necessary).   
 
In some instances, information discussed in multiple sections of labeling in the old format can be 
consolidated in the PLR format.  For example, if the old WARNINGS and old PRECAUTIONS 
sections each contained information about a similar topic, this information should now be 
consolidated under one subsection in the new WARNINGS AND PRECAUTIONS section.  
When consolidating information, subsections can be created and should be put in an order that 
reflects the contents importance and relative public health significance.   
 
In addition, information may need to be reordered to enhance labeling organization, presentation, 
and ease of use (e.g., information in the DOSAGE AND ADMINISTRATION section should be 
reordered to correspond to the order of the presentation of the indications in the INDICATIONS 
AND USAGE section). 
 
B.  Using Cross-References 
 
When a topic is discussed in more than one section of labeling, the section containing the most 
important information relevant to prescribing should typically include a succinct description and 
should cross-reference sections that contain additional detail.  If the detailed information is 
divided appropriately into more than one section, those sections should cross-reference each 
other.  Cross-references from the more detailed discussion to the less detailed discussion should 
generally not be necessary (e.g., a succinct BOXED WARNING should reference the fuller 
discussion of the risk in WARNINGS AND PRECAUTIONS, but the WARNINGS AND 
PRECAUTIONS section should not refer back to the BOXED WARNING).  In some cases, 
cross-references are required (e.g.,  201.57(c)(1), (c)(6)(iv), and (c)(15)(ii)). 
 
C.  Example of the Distribution of Information Among Labeling Sections 
 
Several basic principles are illustrated in the following example.  Although drug interaction 
information has been selected for this example, these principles also apply to other labeling 
sections. 
 
 	  Drug interaction information should typically appear in the DRUG INTERACTIONS and 
CLINICAL PHARMACOLOGY sections.  If there is a subset of information that is essential 
for prescribing decisions, that subset of information can be distributed among several 
sections, including the BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND 
PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections (e.g., 
 201.57(c)(3)(i)(H) and (c)(8)).   
 
 	  When drug interaction information rises to the level of a contraindication, or a warning or 
precaution that necessitates a dosage adjustment, this information should be presented  
 
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  Contains Nonbinding Recommendations  
 
 
succinctly in the applicable section(s), with details in the DRUG INTERACTIONS section ( 
201.57(c)(8)). 
 
   The DRUG INTERACTIONS section contains clinically relevant information, such as the 
need to modify a dose or regimen.  FDA recommends using a descriptive header of summary 
concepts preceding a discussion of specific information (e.g., CYP3A Inhibitors). 
 
   More detail about drug interaction studies, including those demonstrating no drug interaction 
(i.e., pertinent negatives), and any clinically relevant, nonclinical data should be included in 
the CLINICAL PHARMACOLOGY section. 
 
V.  HIGHLIGHTS 
 
The purpose of Highlights is to provide immediate access to the information to which 
practitioners most commonly refer and regard as most important.  Highlights also helps guide the 
practitioner to the section in the FPI where details can be obtained about a specific topic.  The 
following information is intended to help applicants develop Highlights. 
 
A.   General Principles 
 
Highlights should be a concise, informative summary of crucial prescribing information, not a 
verbatim repetition of selected material from the FPI, or a repetition of the Contents.  Rarely, it 
may be appropriate to repeat content verbatim from the FPI (e.g., a succinct boxed warning 
statement or short indication statement), but in most cases, the information should be 
summarized and presented in an easily accessible format (e.g., bulleted, tabular). 
 
The information in Highlights is derived from the FPI.  Selecting the material to include in 
Highlights requires judgment about the importance of the data in relation to the clinical setting in 
which the drug is used. 
 
When information about a risk appears in more than one section of the FPI, the information 
should typically be presented once in Highlights under the most appropriate heading.  For 
example, if a drug interaction is described under Warnings and Precautions in Highlights, it 
should not be repeated under Drug Interactions in Highlights.   
 
Summarized information should be presented in clear language that is succinct and imparts the 
most relevant and complete information.  For example, under Warnings and Precautions, the 
statement in Highlights should, as appropriate, identify the risk, its consequences, and the actions 
to take to prevent or mitigate it.  Directive language is preferable, because it conveys explicit 
information most concisely (e.g., Discontinue, as opposed to You should discontinue).  Each 
summarized statement should be located under the appropriate Highlights heading and must 
cross-reference the section(s) or subsection(s) of the FPI that contains more detailed information 
( 201.56(d)(3)). If new information is to be added to Highlights, the existing information 
should be evaluated and combined so that the new information can be added while maintaining 
the required half page length. 
 
 
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  Contains Nonbinding Recommendations  
 
 
B.   Information in Highlights 
  
The following recommendations focus on the content that should be included in Highlights.  
Because of the importance of the information in Highlights and the space limitations, there are 
specific formatting requirements applicable to Highlights that were designed to enhance 
readability and accessibility of labeling information (see  201.57(d) and section VI of this 
document).  
 
1. 	  Highlights Title and Limitation Statement ( 201.56(d)(1) and 201.57(a)(1)) 
The title HIGHLIGHTS OF PRESCRIBING INFORMATION must be presented at 
the beginning of Highlights ( 201.56(d)(1)).  On the first line under the title, the 
following Highlights Limitation Statement must be presented verbatim in bold: 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) ( 201.57(a)(1) and 201.57(d)(5)). We recommend that the name of the 
drug product be presented in upper case letters to improve its prominence.  
 
2.	   Product Title: Drug Names, Dosage Form, Route of Administration, and 
Controlled Substance Symbol ( 201.57(a)(2)) 
 
The bolded product title consisting of the proprietary name and the established name of 
the drug, if any, or, for biological products, the proper name must be presented,5 followed 
by the dosage form, and route of administration ( 201.57(a)(2) and 201.57(d)(5)).  For 
controlled substances, the symbol for the assigned controlled substance schedule must be 
included at the end of the line ( 201.57(a)(2) and 201.57(d)(5)).   
 
3.	   Initial U.S. Approval ( 201.57(a)(3)) 
 
On the line immediately beneath the product title line, the verbatim statement: Initial 
U.S. Approval must be presented, followed by the bolded four-digit year in which FDA 
initially approved a new molecular entity, new biological product, or new combination of 
active ingredients ( 201.57(a)(3) and 201.57(d)(5)), regardless of dosage form or 
indication (i.e., multiple dates should not be listed for different dosage forms or 
indications). 
 
4.	   Boxed Warning ( 201.57(a)(4)) 
 
The Boxed Warning in Highlights must contain a concise summary of all of the risks 
described in the BOXED WARNING in the FPI ( 201.57(a)(4)) and is limited in length 
to 20 lines, not including the title and required reference to the complete boxed warning 
in the FPI. The title of the Boxed Warning must appear after the word WARNING: and 
must identify the subject(s) of the warning contained in the box (e.g., WARNING:  
ACUTE HEPATIC FAILURE and INFUSION REACTIONS) ( 201.57(a)(4)). The 
                                                 
5 For  drugs, see section  502(e)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  For  biological 
products, see 21 CFR 600.3.   
 
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  Contains Nonbinding Recommendations  
 
 
italicized verbatim statement: See full prescribing information for complete boxed 
warning must be placed immediately following the title of the boxed warning ( 
201.57(a)(4)). FDA recommends that both the title and the verbatim statement be 
centered within the box, and all text within the box must be in bold ( 201.57(d)(5)).   
 
The information summarized under the Boxed Warning heading in Highlights should 
emphasize the information contained in the BOXED WARNING section of the FPI and 
direct attention to the complete box and to the sections in the FPI that contain more 
detailed information.  Because the Boxed Warning in Highlights must be a concise 
summary of the information from the complete BOXED WARNING in the FPI, no 
information should be presented in the Highlights box that does not appear in the FPI box 
( 201.57(a)(4)). There should be only one box in the FPI and one summarized box in 
Highlights, even when multiple topics are presented. 
 
FDA recommends that the information under the Boxed Warning heading in Highlights 
be summarized in a bulleted format.  Formatting should facilitate the clear presentation of 
complex information and risks.  For example, each bullet should communicate a discrete 
warning, clinical indication, or contraindication.  In rare instances, the BOXED 
WARNING in the FPI may be sufficiently concise to warrant repeating the text verbatim  
under the Boxed Warning heading in Highlights.   
 
5.   Recent Major Changes ( 201.57(a)(5))  
 
When substantive labeling changes have been made to any of the following sections of 
the FPI within the preceding 12 months, the heading(s) of the changed section(s) must be 
listed in Highlights under the heading Recent Major Changes ( 201.57(a)(5)):  
 
   Boxed Warning 
   Indications and Usage 
   Dosage and Administration 
   Contraindications 
   Warnings and Precautions 
 
Changes that must not be listed in Recent Major Changes include: 
 
   Changes to sections other than the five listed above 
   Changes that are not substantive (i.e., minor revisions such as correcting 
typographical errors or grammatical changes) 
   Changes resulting from converting to the PLR format alone 
 
a.   What must be included 
 
Each listing must include the section heading, the subsection heading (if appropriate), 
identifying number of the corresponding changed section or subsection, and the date on 
which the change was incorporated in the labeling (i.e., date the supplement was 
approved) in month/year format (e.g., 6/2010 or Jun 2010) ( 201.57(a)(5)). 
 
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  Contains Nonbinding Recommendations  
 
 
 
b.   Multiple labeling changes  
 
If there are changes to more than one section of the labeling, the listings in Recent Major 
Changes must be presented in the order in which they appear in the FPI ( 201.57(a)(5)), 
and not ordered by dates of the changes. 
 
If there is more than one change in the same labeling section or subsection in the 
preceding 12 months, only the newest date should be listed.  For example, if a new 
indication (hypertension) was added to the labeling in March 2011, and a limitation to the 
hypertension indication was added in June 2011, the change under the Recent Major 
Changes heading should be listed as: 
 
Indications and Usage, Hypertension (1.2)  6/2011 
 
Only when space in Highlights permits, if there are changes within a section to more than 
one subsection during the 1-year period listed, each section heading, subsection heading, 
identifying number, and date should be listed separately.  For example: 
 
Indications and Usage, Hypertension (1.2)  6/2011 
Indications and Usage, Heart Failure (1.3)  9/2011 
 
If there are changes within a section to more than one subsection during the 1-year period 
listed and listing subsection headings separately as above would cause Highlights to be 
greater than one-half page in length, only the main section heading should be listed, with 
the date of the most recent change.  For example:  
 
Indications and Usage (1)  9/2011 
 
Experience has shown that listing each changed subsection on a separate line when 
multiple changes have occurred often leads to Highlights that is longer than one-half 
page. Despite not listing each subsection individually in Recent Major Changes, the 
labeling will still enable the reader to readily identify the changes through the use of the 
vertical lines adjacent to the new or modified text in the FPI required by  201.57(d)(9).  
 
c.   Listing related information from different FPI sections 
 
When a drug product is approved for a new indication, new information is often added to 
other sections of labeling (e.g., DOSAGE AND ADMINISTRATION, ADVERSE 
REACTIONS, CLINICAL STUDIES).  If there are changes to any of the five applicable 
sections, each changed section must be listed under the Recent Major Changes heading ( 
201.57(a)(5)). For example: 
 
Indications and Usage, Hypertension (1.2)    6/2011 

Dosage and Administration, Hypertension (2.2)  6/2011 

 
 
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  Contains Nonbinding Recommendations  
 
 
d. 	  Marking text in the FPI with a vertical line 
 
The corresponding new or modified text in the FPI sections listed under Recent Major 
Changes must be marked with a vertical line on the left edge ( 201.57(d)(9)) to alert the 
reader to the new information.  If new text in the FPI is very brief (e.g., 1-2 lines long), it 
may be appropriate to use spacing to extend the vertical line by 1-2 additional lines (e.g., 
mark the blank line before and after the new text) to make it more visible.  Similarly, if a 
new sentence has been added to an existing paragraph, it may be appropriate to mark the 
entire paragraph. 
 
e. 	  Deletions from labeling   
 
Although it is unusual for information to be completely deleted from labeling (e.g., 
removing a warning as opposed to revising it or moving the discussion to a different 
section), if such a situation occurs, the applicant should propose labeling that identifies 
the change in both Recent Major Changes in Highlights and in the FPI. In some cases, the 
deletion may best be addressed by adding new text elsewhere in the FPI; in other cases, 
the Agency will determine how best to identify the change. 
 
f.   Initial submission of revised labeling in the PLR format 
 
Applicants should list under the Recent Major Changes heading any substantive labeling 
changes to the relevant sections that were approved within 1 year of submission of the 
draft labeling for review in the PLR format.   
 
g. 	  Removing a listing from Recent Major Changes  
 
A changed section must be listed under Recent Major Changes for at least 1 year after the 
date the labeling change was approved and can continue to be listed until the labeling is 
reprinted for the first time after the 1-year period expires ( 201.57(a)(5)).  When the 1-
year time period expires, the applicant can choose (1) to reprint labeling immediately to 
remove the listing or (2) to wait until the next reprinting to remove the listing.  Whenever 
a supplemental application is submitted, the applicant should review the labeling changes 
listed under the Recent Major Changes heading and delete any listings that are over 1 
year old. FDA recommends that applicants notify the Agency in an Annual Report about 
removal of a listing from Recent Major Changes and the corresponding vertical line in 
the FPI (see 21 CFR 314.70(b)(2)(v)(C)(1) and 601.12(f)(3)(i)(D)(1)). 
 
h. 	  Listing Recent Major Changes for Changes Being Effected (CBE) 
Supplements6  
 
For labeling changes made through a CBE supplement that meet the criteria for listing in 
Recent Major Changes, the change must be listed under Recent Major Changes for at 
least 1 year after the date the labeling change is made and can continue to be listed until 
the labeling is reprinted for the first time after the 1-year period expires ( 201.57(a)(5)).  
                                                 
6 See  314.70(c)(6) and 601.12(f)(2).  
 
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  Contains Nonbinding Recommendations  
 
 
If a further change is made to the labeling when the Agency approves the CBE 
supplement, the date of approval becomes the new date from which the 1-year period is 
calculated. As above, when the 1-year time  period expires, the applicant can choose to 
(1) reprint labeling immediately to remove the listing or (2) wait until the next reprinting 
to remove the listing.  
 
6.   Indications and Usage ( 201.57(a)(6))  
 
Information under the Indications and Usage heading in Highlights must include a 
concise statement of each of the drugs indications from the FPI, briefly noting any major 
limitations of use ( 201.57(a)(6)).  FDA recommends that the information be presented 
in a bulleted format if multiple indications exist.  In some circumstances, it may be 
appropriate to present the indications with the same wording as in the FPI (e.g., when a 
product has one indication and the statement in the FPI is sufficiently concise).   
 
If the FPI includes any limitations of use, the presentation in Highlights needs to be clear 
as to whether the limitation applies to all indications or only certain indications. For a 
product with limitations of use that are applicable to all of the products indications, it is 
appropriate to list those limitations or concerns together, under an appropriately titled 
subheading (e.g., Limitations of Use).  If the drug is approved under  314.510 or 
601.41 (i.e., an accelerated approval), a statement regarding the basis for approval should 
be included. 
 
If the drug is a member of an established pharmacologic class, the information under 
Indications and Usage must include the statement (Drug) is a (name of class) indicated 
for (indication(s)) ( 201.57(a)(6)). If the drug is not a member of an established 
pharmacologic class, the applicant should propose one.7  The FDA will then determine 
whether to assign a new or existing pharmacologic class to the drug or to omit a 
pharmacologic class entirely.   
 
7.   Dosage and Administration ( 201.57(a)(7)) 
 
Information under the Dosage and Administration heading must contain a concise 
summary of the recommended dosage regimen (e.g., starting dose, dose range, titration 
regimens, route of administration), critical differences among population subsets, 
monitoring recommendations, if any, and other clinically significant clinical 
pharmacology information that affects dosing recommendations (e.g., dosing adjustments 
recommended for concomitant therapy, specific populations with coexisting conditions, 
clinically relevant food effects) ( 201.57(a)(7)).  FDA recommends a tabular format to 
                                                 
7 See FDA Guidance for Industry: Labeling for Human Prescription Drug and Biological Products  Determining  
Established Pharmacologic Class for Use in the Highlights of Prescribing  Information and the web page on  
pharmacologic class at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162549.htm. 
 
We update  guidances  periodically.  To make sure you  have the most recent version of a guidance, check the FDA  
Drugs guidance web site at  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
  11
  Contains Nonbinding Recommendations  
 
 
enhance accessibility of information as appropriate (e.g., when there are complex dosage 
regimens or different dosing regimens for different indications).   
 
In general, every attempt should be made to include the critical dosing and administration 
information in Highlights.  However, there may be instances when a cross-reference to 
the FPI for detailed information may be necessary for a product with complex dosing and 
administration information.  In such instances, a statement should be included under the 
Dosage and Administration heading in Highlights to alert the prescriber that additional 
important information is in the FPI. 
 
8.   Dosage Forms and Strengths ( 201.57(a)(8)) 
 
Information under the Dosage Forms and Strengths heading must include all available 
dosage forms and strengths (see  201.57(a)(8)) to assist the prescriber in product 
selection. If a solid oral dosage form is functionally scored, such information must be 
included8 ( 201.57(a)(8)). If a drug product has numerous dosage forms, bulleted 
subheadings (e.g., capsules, suspension, injection) or tabular presentations are 
recommended. For some products, including limited information on packaging can 
facilitate prescribing (e.g., noting that a 0.5% topical cream  is available in both 15 g and 
30 g tubes). Because of space constraints in Highlights, multiple strengths for a dosage  
form should be listed on one line (e.g., Tablets: 25 mg, 50 mg, 100 mg, and 200 mg).  
Descriptors of the product appearance (e.g., tablet color, shape, embossing) that appear in 
DOSAGE FORMS AND STRENGTHS in the FPI should not appear in Highlights. 
 
9.   Contraindications ( 201.57(a)(9)) 
 
Information under the Contraindications heading must include a list of all the 
contraindicated situations described in the FPI or the word None if no contraindicated 
situations have been identified ( 201.57(a)(9)).  FDA recommends that each 
contraindication be identified in a bulleted list.  
 
As in the FPI, theoretical contraindications should not be included in Highlights.  For 
example, some labeling has included a contraindication in patients with hypersensitivity 
to any of the drug products components, despite there being no such reports and no basis 
upon which to believe such a risk exists.  For labeling being converted to PLR format, 
these theoretical contraindications should be removed. If such data do exist, Highlights 
should include the hypersensitivity contraindication, and the CONTRAINDICATIONS 
section in the FPI should, in addition, describe the type and nature of the reactions that 
have been reported. Similarly, circumstances under which the drug may be used with 
caution are not contraindications and are not appropriate for inclusion.   
 
                                                 
8 A draft guidance is available on this issue. See Tablet Scoring: Nomenclature, Labeling,  and Data for Evaluation  
for FDAs current thinking on this topic. Once finalized, this guidance will represent the Agencys perspective on  
this issue  
 
 
  12
  Contains Nonbinding Recommendations  
 
 
10.   Warnings and Precautions ( 201.57(a)(10)) 
 
Information under the Warnings and Precautions heading must include a concise 
summary of the most clinically significant safety concerns from the FPI that affect 
decisions about whether to prescribe the drug, recommendations for patient monitoring to 
ensure safe use of the drug, and measures that can be taken to prevent or mitigate harm ( 
201.57(a)(10)). Individual risk topics should be presented in a bulleted format, with each 
imparting a complete piece of information (e.g., identify the risk, its consequences, and 
recommendations for the clinician to prevent or mitigate it, as appropriate).  For example: 
 
   Infusion reactions: Severe reactions have been reported.  Discontinue DRUG-X for 
severe reactions; consider pre-treatment for cycles subsequent to milder reactions. 
(5.X). 
 
The presentation should not merely be a list of subsection headings from Contents.  
Ambiguous and uninformative information (e.g., use with caution) and terminology that 
describes a contraindication (e.g., do not use...) should be avoided.   
 
The most clinically significant safety concerns should be presented in Highlights; 
however, not all of the safety information from the FPI will always be included in 
Highlights. The order of the information should be the same as that of the FPI 
WARNINGS AND PRECAUTIONS section, reflecting the nature and severity of the 
risks. As previously stated, it is generally not necessary or useful to repeat information if 
it appears in other sections of Highlights. 
 
11.   Adverse Reactions ( 201.57(a)(11)) 
 
a.   Most frequently occurring adverse reactions 
 
Information under the Adverse Reactions heading must include (1) a listing of the most 
frequently occurring adverse reactions, even if one or more are included elsewhere in 
Highlights (e.g., under the Warnings and Precautions heading) and (2) the criteria used to 
determine inclusion (e.g., frequency cutoff rate) ( 201.57(a)(11)(i)).  The listing should 
be concise, not lengthy or comprehensive, and reactions should be presented in 
decreasing order of frequency. Specific terms should be used (e.g., neutropenia rather 
than hematologic) because general terms may not adequately describe the risk. 
 
The list of adverse reactions identified as most frequently occurring or most common is 
usually generated from a table of adverse reactions from clinical trials in the FPI.  Rates  
of most common adverse reactions vary, but should be appropriate to the nature of a 
drugs adverse reactions profile and the size and composition of the safety database.  If 
adverse reaction profiles vary significantly for different indications, the most common 
adverse reactions should be presented separately for each indication.   
 
 
 
  13
  Contains Nonbinding Recommendations  
 
 
b.   Adverse reaction reporting contact information 
 
Highlights must also contain adverse reaction reporting contact information, in bold type, 
that includes the following ( 201.57(a)(11)(ii), (iii), (iv) and 201.57(d)(5)):  
 
-  The verbatim statement To report SUSPECTED ADVERSE REACTIONS, 
contact followed by the manufacturers name and phone number for adverse 
reaction reporting 
-  The address of a manufacturers web site for voluntary reporting of adverse 
reactions (only if such a web site exists)9   
-  FDAs phone number and web address for voluntary reporting of adverse reactions 
(see below). 
 
FDAs phone numbers and web addresses for voluntary reporting of adverse 
reactions: 
 
For drug and biological products (other than vaccines)  
MedWatch 
Phone number: 1-800-FDA-1088 
Web address: www.fda.gov/medwatch 
 
For vaccines  
VAERS  
Phone number: 1-800-822-7967 
Web address: www.vaers.hhs.gov 10   
 
For example, the completed adverse reaction reporting contact information statement for 
a drug product would read: 
 
To report SUSPECTED ADVERSE REACTIONS, contact [name of 
manufacturer] at [manufacturers phone number] or FDA at 1-800-FDA-1088 
or www.fda.gov/medwatch. 
 
The intent of this requirement is to encourage reporting of suspected adverse reactions.  
The rule specifically requires the inclusion of a phone number and, if available, the web 
address of the direct link to a site dedicated to adverse reaction reporting.  Such dedicated 
web sites and phone lines provide a structured process for reporting adverse reactions 
(i.e., telephone interview, a form, or instructions for reporting), whereas an e-mail 
address or link to a company or product web site does not.  An e-mail address or a link to 
the homepage of a companys web site cannot be used to meet the requirement for 
adverse reactions reporting contact information in Highlights ( 201.57(a)(11)(iv)).  
Although not specifically required in these labeling regulations, the phone number 
                                                 
9 If a manufacturer does not have a web site for voluntary  reporting of adverse reactions, the manufacturer is  not
  
required to create one. 

10 For vaccines, this web address is also used  for reporting required by health care professionals.   

 
 
  14
  Contains Nonbinding Recommendations  
 
 
provided should be a toll-free number to encourage reporting by practitioners and 
consumers.   
 
If more than one entity is responsible for the product (e.g., the product is manufactured 
by one company and marketed by another, or the product is co-marketed), only one 
contact should be listed (e.g., the name of the entity identified by agreement between the 
companies as the recipient of safety information).    
 
12.   Drug Interactions ( 201.57(a)(12)) 
 
Information under the Drug Interactions heading must include a concise summary of 
those drugs (or classes of drugs) or foods that interact or are predicted to interact in 
clinically significant ways with the subject drug, and practical instructions for preventing 
or managing the interaction ( 201.57(a)(12)). 
 
Interaction information in Highlights should reflect the ordering of the DRUG 
INTERACTIONS section in the FPI, which is based on the relative clinical significance 
of the information.  Descriptive subheadings of summary concepts (e.g., CYP3A 
inhibitors) can precede specific information.  Rarely, it may be appropriate to include 
pertinent negative findings of drug interaction studies under this heading if the interaction 
would otherwise be anticipated or is of special concern. 
 
If there are no clinically significant drug interactions, the heading should be omitted from  
Highlights. Information about lack of drug interactions or drug interactions that are not 
clinically relevant should not be included in Highlights.   
 
Interactions with serious clinical consequences that are summarized elsewhere in 
Highlights (e.g., in the Boxed Warning or under the Contraindications or Warnings and 
Precautions heading) should be described in greater detail in the DRUG 
INTERACTIONS section in the FPI and need not be repeated under the Drug 
Interactions heading in Highlights. 
 
Because some drugs have numerous clinically significant drug interactions, it may not be 
possible to concisely summarize all the critical information in Highlights.  In these 
instances, a statement can be included under the Drug Interactions heading in Highlights 
that alerts the prescriber to the presence and significance of the drug interaction 
information in the FPI.   
 
13.   Use in Specific Populations ( 201.57(a)(13)) 
 
Information under the Use in Specific Populations heading must include a concise 
summary of any clinically important differences in response or recommendations for use 
of the drug in specific populations from the FPI (e.g., differences between adult and 
pediatric responses, need for specific monitoring in patients with hepatic impairment) ( 
201.57(a)(13)).  If multiple populations are described under this heading, they should be 
presented in the same order in which they appear in the FPI. 
 
  15
  Contains Nonbinding Recommendations  
 
 
 
If there are no clinically important differences in response or recommendations for use of 
the drug in specific populations, the heading should be omitted from Highlights.  
Ordinarily, the absence of information about the safety and effectiveness of a drug in a 
specific population (e.g., pregnant women, children) should not be included under this 
heading. In unusual circumstances, if describing the absence of data provides important 
information for the prescriber, the heading should be retained.  For example, if a drug has 
not been adequately studied in a specific patient population (e.g., those with hepatic 
impairment), Highlights may include a bullet describing the lack of information if 
deemed essential for prescribing decisions in that specific population.   
 
The pregnancy category designation is not appropriate for inclusion in Highlights 
because, in isolation, it tends to oversimplify the risks of drugs in pregnancy and, as a 
result, may be confusing.  Decisions about use of a drug in pregnancy should be based on 
careful consideration of available data, not simply on a reference to the pregnancy 
category. Information about the availability of a pregnancy registry and enrollment 
information should not appear in Highlights because it is not essential information and 
does not affect prescribing decisions. Registry information should be included in the 
Pregnancy subsection of the USE IN SPECIFIC POPULATIONS section of the FPI.   
 
If information about use in specific populations is included under other headings in 
Highlights (e.g., Contraindications, Warnings and Precautions, Dosage and 
Administration), it should not be repeated under this heading. 
 
14.   Patient Counseling Information Statement ( 201.57(a)(14)) 
 
Highlights must contain the statement See 17 for PATIENT COUNSELING 
INFORMATION in bold or, if the product has FDA-approved patient labeling, See 17  
for PATIENT COUNSELING INFORMATION and FDA-approved patient 
labeling, or if the product has a Medication Guide, See 17 for PATIENT 
COUNSELING INFORMATION and  Medication Guide ( 201.57(a)(14) and 
201.57(d)(5)). If the product has both a Medication Guide and another type of FDA-
approved patient labeling (e.g., Instructions for Use), the statement should refer only to 
the Medication Guide. If the product has more than one type of FDA-approved patient 
labeling other than a Medication Guide (e.g., Patient Package Insert, Patient Information, 
Instructions for Use), the statement should refer only to FDA-approved patient labeling.   
 
15.   Revision Date ( 201.57(a)(15)) 
 
At the end of Highlights, the date of the most recent revision of the labeling must be 
presented ( 201.57(a)(15)). The preferred format is Revised: Month Year or Revised: 
Month/Year in bold type (i.e., Revised: Apr 2011 or Revised: 4/2011). In PLR 
format, this statement replaces the revision date that appears at the end of labeling in the 
old format ( 201.56(e)(5)).  A new approval or changes to the approved labeling will 
trigger a new revision date. FDA-approved patient labeling or Medication Guides can 
 
  16
  Contains Nonbinding Recommendations  
 
 
have revision dates that differ from the revision date at the end of Highlights, if 
appropriate. 
 
 	  For labeling requiring prior approval (e.g., original applications, efficacy 
supplements, prior approval labeling supplements), the revision date would be the 
date of application approval. Manufacturers should leave this field blank and FDA 
will populate it at the time of approval.  
 
 	  For CBE supplement labeling ( 314.70(c)(6) and 601.12(f)(2)), the revision date 
generally is the date of application receipt.  Manufacturers should populate the 
revision date field with the date they anticipate FDA will receive the supplement.  If  
the labeling text is changed by FDA, the revision date will be changed to the date of 
CBE approval. 
 
 	  For annual report labeling, the revision date should reflect the date that the revised 
labeling is submitted to FDA.  If all such changes are bundled and submitted once a 
year with the annual report, the revision date should be the date of the receipt of the 
annual report. 
  
VI.  FORMATTING  
 
The final rule includes formatting requirements (e.g., ordering, numbering, type size) that were 
designed to enhance readability and accessibility of labeling information ( 201.57(d)).  
Attention to the formatting requirements of Highlights is particularly important because the most 
important prescribing information is presented in limited space (see Appendix E, which 
illustrates a sample Highlights and Contents).  Although Appendix E illustrates every possible 
section and subsection, it is only an example, and not all drugs will have entries for all sections 
or subsections presented. FDA recommends the use of a two-column format for Highlights and 
Contents and use of adequate white space in Highlights (e.g., between each section) because 
these formatting techniques enhance effective communication of the labeling information.  
Beyond these requirements and recommendations, FDA expects that some flexibility in 
formatting will be necessary because of variability in the type and quantity of labeling  
information for different drugs.  Other recommendations for formatting issues are described 
below. 
 
A.  Subsection Headings 
 
Some subsections are required (e.g., 8.1 Pregnancy, 12.1 Mechanism of Action) ( 201.56(d)(1)).  
The use of additional subsection headings is encouraged to help organize and identify the content 
of the information in the FPI (e.g., to identify individual warnings).  Subsection headings that are 
not useful for signaling the content of the subsection, such as General or Miscellaneous should 
be avoided. Each subsection heading must be assigned a decimal number that corresponds to its 
placement in the FPI ( 201.56(d)(2) and 201.57(c)).   
 
Subheadings under a subsection may be used to help organize information within a subsection, 
but they should not be assigned a numerical identifier with an additional decimal point (e.g., 
 
  17
  Contains Nonbinding Recommendations  
 
 
12.3.1) nor should they appear in Contents.  Instead, other formatting techniques (e.g., italics or  
underlining) can be used to achieve emphasis. 
 
B.  Omitted Sections  ( 201.56(d)(4))  
 
Any section, subsection, or specific information that is clearly inapplicable must be omitted from  
labeling ( 201.56(d)(4)).  Additionally, in most cases, when clinically relevant information 
about a drug is not available, the section or subsection should be omitted.  Examples of 
appropriate omissions include the following: 
 
   The DRUG ABUSE AND DEPENDENCE section should be omitted for a drug that is 
not a controlled substance and has no potential for abuse or dependence. 
   The subsection Geriatric Use in the USE IN SPECIFIC POPULATIONS section should 
be omitted for a drug indicated only in neonates.    
 
When a section or subsection is omitted from the FPI, it must also be omitted from the Contents 
( 201.56(d)(4)). The heading Full Prescribing Information:  Contents must be followed by an 
asterisk and the following statement must appear at the end of the Contents:  *Sections or 
subsections omitted from the full prescribing information are not listed ( 201.56(d)(4)).  When 
there is an omission from the labeling, the numbering outlined in  201.56(d)(1) should be 
preserved (i.e., subsequent sections and subsections are not renumbered). 
 
In most cases when clinically relevant information about a drug is not available, the section or 
subsection should be omitted. In a few cases, describing the absence of data can provide 
important information for the prescriber, and, in these instances, the section or subsection should 
be included. For example, if a drug has not been adequately studied in a patient population with 
renal impairment, the labeling should typically include a Renal Impairment subsection under 
USE IN SPECIFIC POPULATIONS stating the lack of information.  
 
C.  Cross-References 
 
Cross-referencing is encouraged, and in some  cases required (e.g.,  201.57(c)(1), (c)(6)(iv) and 
(c)(15)(ii)) because it refers the reader to more or related information on the topic and reduces 
the need to repeat detailed information about a similar issue in several different sections (see 
IV.B of this guidance for more information).   
 
The preferred presentation of cross-references in Highlights is the numerical identifier in 
parentheses following the summarized labeling information (e.g., (5.1)).  The preferred 
presentation of cross-references in the FPI is the section heading followed by the numerical 
identifier (e.g., [see Warnings and Precautions (5.1)]). Because cross-references are embedded 
in the text in the FPI, we encourage the use of italics to achieve emphasis. 
 
D.  Type Size and Font Type 
 
The final rule requires different minimum type sizes for trade labeling (i.e., labeling on or within 
the package from which the drug is to be dispensed, including product samples) and for labeling 
 
  18
  Contains Nonbinding Recommendations  
 
 
disseminated in other settings (e.g., labeling that accompanies prescription drug promotional 
materials) (see  201.57(d)(6)).  Appendix D shows minimum type size requirements for labeling 
in the PLR format ( 201.57) and in the old format ( 201.80), including requirements for FDA-
approved patient labeling ( 201.57(c)(18) and 201.80(f)(2))).  FDA encourages a minimum 
type size of 10 points for all FDA-approved patient labeling. 
 
There is no requirement for a specific font type (or typeface) for labeling, but the font type 
should be clear and legible. For example, narrow font types (e.g., Arial Narrow) are not 
recommended because they are difficult to read and may render the labeling illegible.  
 
E.  Use of Abbreviations 
 
Once an abbreviation for a term is defined in Highlights, FDA recommends redefining it the first 
time it is used in the FPI.  Because labeling is frequently used to find a specific piece of 
information and the labeling may not be read from beginning to end, an acronym may be several 
pages away from where it was first defined in Highlights.   
 
Unambiguous, commonly understood abbreviations (e.g., mg for milligrams) do not need to be 
defined. Abbreviations for units of measure (e.g., mg, mL) should be consistent within container 
and carton labeling. FDA recommends that Latin abbreviations (e.g., QD, QID) be avoided 
because of the greater potential for medication errors should an abbreviation be misread.11    
 
 
VII.  PROCEDURAL INFORMATION 
 
A.  Applications Covered by the Final Rule  
 
Section 201.56(b)(1) provides that the final rule applies to prescription drug products with a new 

drug application (NDA), biologics license application (BLA), or efficacy supplement that 

 
   is submitted on or after June 30, 2006 (the effective date of the final rule), 
  
   is pending with the Agency on June 30, 2006, or  

   was approved in the 5 years prior to June 30, 2006.   

 
Although FDA recognizes the effort involved in revising labeling, the Agency strongly believes 

that the PLR format is an important advance in communicating drug information.  Therefore, we 

encourage applicants with products to which the final rule does not apply to voluntarily convert 

the labeling of their products to the PLR format.   

 
1.  New NDAs, BLAs, and Efficacy Supplements 
 
Draft labeling for new NDAs, BLAs, and efficacy supplements must be submitted in the 
PLR format ( 201.56(c)(1)).   
                                                 
11 For additional information on abbreviations and dose designations that can lead to medication errors, see the 
ISMP  List of  Error-Prone Abbreviations, Symbols, and Dose Designations  
http://www.ismp.org/tools/errorproneabbreviations.pdf. 
 
  19
  Contains Nonbinding Recommendations  
 
 
 
The following efficacy supplements trigger the requirement to revise labeling to the PLR 
format: 
 
   Adding or modifying an indication or claim  
   Revising the dose or dose regimen  
   Providing for a new route of administration 
   Making a comparative efficacy claim naming another product 
   Significantly altering the intended patient population  
   Providing for, or providing evidence of effectiveness necessary for, the traditional 
approval of a product originally approved under subpart H of part 314 or part 601 
   Incorporating other information based on at least one adequate and well-controlled 
clinical study 
   Pediatric supplements in response to written requests and the Pediatric Research 
Equity Act (PREA) of 200712  
 
Examples of supplements that do not trigger the requirements to revise labeling to the 
PLR format include NDA supplements for a new tablet strength; supplements that 
provide bioequivalence information, chemistry, manufacturing, and controls, also known 
as a CMC supplement, including one that contains clinical data but for which the data 
do not affect labeling (e.g., reformulation); and supplements that add new risk 
information (e.g., a new contraindication, warning).   
 
2.  Approved Applications 
 
The timing for submitting labeling in the PLR format is based on the implementation plan 
(see  201.56(c) and Appendix A), but an applicant can voluntarily convert product 
labeling to the PLR format before the date specified in the implementation plan and is 
encouraged to do so. When more than one approval for the same product occurred in the 
5 years prior to the effective date of the final rule (e.g., NDA and efficacy supplement), 
the date of the most recent approval determines the timing of submission of labeling in 
the PLR format according to the implementation plan.   
 
The labeling must be submitted as a prior approval labeling supplement.13  After labeling 
is approved in the PLR format, any subsequent changes to Highlights, other than 
identified minor exceptions, require submission of a prior approval supplement ( 
314.70(b), (c), and (d) and 601.12(f)). 
 
3.  Submitting Draft Labeling to FDA for Review 
 
To facilitate FDAs review of labeling, when a significant amount of new information is 
being added to the labeling at the same time  that the labeling is being converted to the  
                                                 
12 Section 505A and 505B of the Federal Food, Drug  & Cosmetic Act, as amended by the Food and  Drug 

Administration Amendments Act of  2007  (P. L. 110-85)
 
13 See  314.70(b) and 601.12(f) about supplements requiring FDA approval before the change is made. 

 
 
  20
  Contains Nonbinding Recommendations  
 
 
PLR format (e.g., an efficacy supplement that also converts labeling to the PLR format), 
we recommend that the following versions of labeling be submitted as appropriate:  
 
   Labeling in the old format  
   Annotated labeling in the old format explaining how existing text was incorporated 
into the PLR format 
   A clean version (no redline/strikeout) in the PLR format without the new 
information  
   The above clean  version in the PLR format with the new information (in 
redline/strikeout) 
 
For the example listed above, if the efficacy supplement is to be reviewed in a division 
other than the one that managed the original application, two supplements should be 
submitted (i.e., a labeling supplement and an efficacy supplement). 
 
Applicants should explain significant or notable changes in wording or content, or 
relocation of information to a different section, and how the decisions to make those 
changes were made.  For submissions covering only a conversion of existing labeling to 
PLR format (without adding new information), the applicant should mark clearly on the 
cover letter, Labeling/PLR Conversion to facilitate identification of the type of 
submission for FDA.  
 
B.  Changes to the Regulations for Applications Not Covered by the Final Rule 
 
FDA has also made minor amendments to the labeling regulations for prescription drug and 
biological products not subject to the PLR content and format requirements (see  201.56(e) 
and 201.80). Section 201.80 remains largely unchanged from previous labeling regulations, 
except for minor revisions to the REFERENCES section and the requirement to append FDA-
approved patient labeling to the prescribing information by June 30, 2007.  As always, labeling 
must be informative and accurate and neither promotional in tone nor false or misleading in any 
particular ( 201.56(a)(3)). Therefore, the applicant should review the labeling at least annually 
for outdated information.  Removing outdated references could be submitted in the Annual 
Report. 
 
C.  Appending FDA-Approved Patient Labeling  
 
The final rule required that by June 30, 2007, any FDA-approved patient labeling either 
accompany the labeling or be reprinted immediately following the last section of the labeling ( 
201.56(e)(6), 201.57(c)(18) and 201.80(f)(2)).14  This requirement applies to the labeling of all 
drugs, not just those subject to the PLR format requirements.  The final rule provides the option 
of either reprinting the FDA-approved patient labeling (including Medication Guides) 
immediately following the last section of labeling or having the FDA-approved patient labeling 
accompany the labeling as a separate document (e.g., included in the carton with the drug).   
                                                 
14 The term  FDA-approved patient  labeling refers to any labeling that has been reviewed and approved by  FDA that  
provides information for patients and is intended for distribution to  patients who are prescribed a drug.  
 
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In addition, any FDA-approved patient labeling must be referenced in the PATIENT 
COUNSELING INFORMATION section ( 201.57(c)(18) in the PLR format or in the 
Information for Patients subsection ( 201.80(f)(2) in the old format).  A statement referring the 
reader to FDA-approved patient labeling should appear at the beginning of the section or 
subsection. 
 
The FDA-approved patient labeling should not be a numbered subsection under the PATIENT 
COUNSELING INFORMATION section in the FPI or listed in Contents, but appended or 
reprinted after the last section of labeling.   
 
Including only the FDA-approved patient labeling as the content of the PATIENT 
COUNSELING INFORMATION section does not meet the requirements of the final rule ( 
201.57(c)(18) and 201.80(f)(2)). FDA-approved patient labeling and the information in the 
PATIENT COUNSELING INFORMATION section have distinct purposes.  The PATIENT 
COUNSELING INFORMATION section of the FPI is written for health care professionals and 
contains the information that is important to convey to patients when the drug is being 
prescribed, dispensed, or administered.  The FDA-approved patient labeling is written for 
patients to provide them with information about the drug that has been prescribed.  FDA believes 
that both of these are important tools for providing information to patients. 
 
D.   Submitting Electronic Versions of Labeling  
 
For information about submitting labeling electronically, applicants should consult the 
information and guidances for industry on FDAs web site on Structured Product Labeling 
Resources.15  
 
E.   Waivers and CBE Supplements 
 
	   Waivers: Requests to waive a labeling requirement under  314.90(a) or 201.58 should be 
submitted directly to the application with any related communication directed to the 
responsible review division.  A waiver request may pertain to a labeling requirement 
described in  201.56, 201.57, 201.80, or 314.50(l)(i).  The applicant should clearly identify 
the submission as a request for a waiver.   
 
	   Waivers of the one-half page Highlights requirement:  The PLR regulations require that 
Highlights, excluding the boxed warning, be limited in length to one-half page ( 
201.57(d)(8)). Applicants should strive for this one-half page limit, using recommendations 
included in this guidance (e.g., avoiding redundancy of information, use of directive 
language, and inclusion of succinct bulleted lists).  However, FDA recognizes that under 
certain circumstances, particularly when a product has many indications or many serious 
warnings and precautions that merit inclusion in Highlights, it may not be possible to 
accommodate all the required information within one-half page.  In this case, the applicant 
                                                 
15  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. 
 
 
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can submit a waiver request with the submission (e.g., NDA, BLA, efficacy supplement, or 
labeling supplement) (see  201.58.).   
 
  The applicant should prominently identify the submission as one that includes a waiver 
request. In the waiver request, the applicant should explain why the one-half page 
requirement cannot be met.  FDA will discuss the waiver request with the applicant during 
the review process and will formally document its decision in an action letter to the applicant.   
 
 	  Changes to Highlights through a CBE supplement:  With minor exceptions, changes to 
Highlights require a prior approval supplement ( 314.70 and 601.12).  If the labeling is 
already approved in the PLR format and the proposed change(s) qualify for a CBE 
supplement under  314.70(c) and 601.12(f), a prior approval supplement is not needed as 
long as the change does not warrant inclusion in Highlights (e.g., addition of an adverse 
reaction to the ADVERSE REACTIONS section in the FPI).  If, in the opinion of the 
applicant, the new information warrants inclusion in Highlights or will be listed under Recent 
Major Changes in Highlights (i.e., a change to the BOXED WARNING,  
CONTRAINDICATIONS, OR WARNINGS AND PRECAUTIONS sections), the applicant 
should notify the appropriate review division about the proposed change to the labeling.  The 
review division may permit changes to Highlights through a CBE supplement after 
consideration of the new information.   
 
F.   Class Labeling 
 
1.  Mandated Statements 
 
In some instances, a statement for a drug or class of drugs is required by regulation to be 
included in a particular section of the labeling (e.g., 21 CFR 310.517 requires that 
labeling for oral hypoglycemics of the sulfonylurea class include a statement in the 
WARNINGS section). When converting labeling to the PLR format, any required 
statement should be included in the corresponding section in the PLR format (e.g., a 
statement required to be included in the BOXED WARNING in the old format should be 
included in the BOXED WARNING in the PLR format).  For sections that have been 
altered or eliminated, see Appendix C for the location of the statement in the PLR format. 
 
In cases where the regulation requires a statement, but the rule does not specify where the 
statement should appear, FDA will consider, on a case-by-case basis where those 
statements should appear in the PLR format.  Whether a specific statement required by 
regulation must appear in Highlights will be determined by FDA.  
 
2.  Class Labeling Statements That Are Not Mandated by Regulation 
 
In some cases, the labeling of all members of a class of drugs includes identical 
statements, even though they are not mandated by regulation.  These class labeling 
statements describe a risk or effect that is typically associated with members of the class, 
based on what is known about the pharmacology or chemistry of the drugs.  For example, 
 
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the boxed warning about the risk of using an ACE inhibitor during the second and third 
trimesters of pregnancy is uniformly presented in all labeling for this class of drugs.   
 
To ensure consistent presentation of class labeling statements within drug classes, FDA 
will determine the appropriate content and location of a class labeling statement in 
Highlights and the FPI. 
  
G.  Abbreviated New Drug Application (ANDA) Products  
 
Under 21 CFR 314.94(a)(8), the labeling of a drug product submitted for approval under an 
ANDA must be the same as the labeling of the listed drug referenced in the ANDA, except for 
changes required because of the following: 
 
   Differences have been approved under a suitability petition filed under 21 CFR 314.93.  
   The ANDA product and the reference listed drug are produced or distributed by different 
manufacturers. 
   Aspects of the listed drugs labeling are protected by patent or exclusivity.  
  
Thus, if the labeling of the reference listed drug is converted to the PLR format, the labeling of 
the ANDA product must also be revised in accordance with 21 CFR 314.127(a)(7).     
 
H.  505(b)(2) NDA Products 
 
In general, the applicant submitting an application under section 505(b)(2) of the FD&C Act 
need not wait for changes to be made to the referenced products labeling to convert its labeling 
to the PLR format.  For specific cases when an applicant may feel such a delay is warranted, a 
waiver from the requirements for the PLR format can be requested.  If the section 505(b)(2) 
product labeling is converted to the PLR format before the referenced product, and substantial 
changes are made to sections referenced by the section 505(b)(2) product when the referenced 
product labeling is converted, FDA may request additional changes to the labeling of the section 
505(b)(2) product in accordance with existing regulations and policies. 
 
I.  Manufacturer Information 
 
Under  201.1, labeling must include the name  and place of business of the manufacturer, 
packer, or distributor. Traditionally, this has been printed at the end of the labeling (after the 
HOW SUPPLIED section).  In the PLR format, manufacturer information should be located at 
the end of the labeling, after the PATIENT COUNSELING INFORMATION section.  If the 
product has FDA-approved patient labeling that is not a separate document or not intended to be 
detached and distributed to patients, the manufacturer information should be located at the end of 
the labeling, after the FDA-approved patient labeling.  If the FDA-approved patient labeling is a 
separate document or is to be detached and distributed to patients, the manufacturer information 
should be located both after the PATIENT COUSELING INFORMATION section and after the 
FDA-approved patient labeling. 
 
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VIII.  ADDITIONAL LABELING GUIDANCES 
 
FDA has issued several additional guidances for industry on prescription drug labeling.  FDA 
guidances are available on FDAs guidance web site. 
(http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm.) The web 
site is updated regularly as new or revised guidances are published.   
 
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  Contains Nonbinding Recommendations  
 
 
APPENDIX A  Implementation Plan 
 
 
Applications (NDAs, BLAs, and Efficacy  Time by Which Conforming Labeling 
Supplements) Required to Conform to  Must Be Submitted to the Agency for 
PLR Labeling Requirements  Approval 
Applications submitted on or after June 30,  Time of submission 
2006   
   
Applications pending on June 30, 2006,  June 30, 2009 
and applications approved any time from    
June 30, 2005, up to and including June 30,   
2006   
   
Applications approved any time from June  June 30, 2010 
30, 2004, up to and including June 29,   
2005   
   
Applications approved any time from June  June 30, 2011 
30, 2003, up to and including June 29,   
2004   
   
Applications approved any time from June  June 30, 2012 
30, 2002, up to and including June 29,   
2003   
   
Applications approved any time from June  June 30, 2013 
30, 2001, up to and including June 29,   
2002   
   
Applications approved prior to June 30,  Voluntarily at any time  
2001 
 
 
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APPENDIX B  Prescription Drug Labeling Sections 
 
Old Format*  PLR Format** 
Description  HIGHLIGHTS OF PRESCRIBING INFORMATION 
Clinical Pharmacology     Product Names, Other Required Information 
Indications and Usage     Boxed Warning 
Contraindications  Recent Major Changes 
Warnings  Indications and Usage 
Precautions      Dosage and Administration 
Adverse Reactions      Dosage Forms and Strengths 
Drug Abuse and Dependence  Contraindications 
Overdosage     Warnings and Precautions 
Dosage and Administration  Adverse Reactions 
How Supplied  Drug Interactions 
  Use in Specific Populations 
Optional sections:   
   Animal Pharmacology  FULL PRESCRIBING INFORMATION: CONTENTS  
    and/or Animal Toxicology   
Clinical Studies  FULL PRESCRIBING INFORMATION 
References  Boxed Warning 
  1 Indications and Usage 
   2 Dosage and Administration 
   3 Dosage Forms and Strengths 
4 Contraindications 
   5 Warnings and Precautions 
6 Adverse Reactions 
7 Drug Interactions 
8 Use in Specific Populations 
9 Drug Abuse and Dependence 
10 Overdosage 
11 Description 
  12 Clinical Pharmacology 
13 Nonclinical Toxicology 
14 Clinical Studies 
15 References 
16 How Supplied/Storage and Handling 
  17 Patient Counseling Information 
* As required by 21 CFR 201.56(e) and 201.80. 
**As required by 21 CFR 201.56(d) and 201.57 
 
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APPENDIX C  Reorganizing Labeling Sections 
 
 
Location in Old Format        Location in FPI in PLR Format 
 
Boxed Warning        Boxed Warning 
Description          Description 
Clinical Pharmacology      Clinical Pharmacology 
Indications and Usage       Indications and Usage 
Contraindications      Contraindications 
Warnings           Warnings and Precautions 
Precautions  
  General           Warnings and Precautions 

  Information for Patients      Patient Counseling Information  

  Laboratory Tests       Warnings and Precautions 

  Drug Interactions      Drug Interactions  

  Drug/Laboratory Test  

Interactions     Warnings and Precautions 
  Carcinogenesis, Mutagenesis, 
Impairment of Fertility    Nonclinical Toxicology (Carcinogenesis,  
Mutagenesis, Impairment of Fertility) 
Pregnancy         Use in Specific Populations (Pregnancy) 
Labor and Delivery       Use in Specific Populations (Labor and Delivery) 
  Nursing Mothers       Use in Specific Populations (Nursing Mothers) 
  Pediatric Use         Use in Specific Populations (Pediatric Use) 
  Geriatric Use         Use in Specific Populations (Geriatric Use) 
Adverse Reactions         Adverse Reactions  
Drug Abuse and Dependence     Drug Abuse and Dependence 
Overdosage          Overdosage 
Dosage and Administration       Dosage and Administration 
How Supplied         Dosage Forms and Strengths  
   How Supplied/Storage and Handling 
Animal Pharmacology  
and/or Animal Toxicology     Nonclinical Toxicology (Animal Toxicology and/or  
            Pharmacology) 
Clinical Studies         Clinical  Studies 
References           References 
 
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APPENDIX D  Type Size Requirements for Labeling and FDA-Approved Patient 

Labeling Included with Labeling 

 
  Type Size   FDA-Approved Patient Labeling  Type Size  
Requirements  Included  Requirements 
for Labeling   with Labeling  for FDA-Approved 
Patient Labeling 
PLR Format (21 CFR 201.57) 
Trade Labeling  Minimum 6-point  FDA-approved patient labeling that  Minimum 6-point type 
(i.e., labeling  type  is not for distribution to patients 
on or within   
the package  Any FDA-approved patient labeling  Minimum 6-point type*  
from which the  (except a Medication Guide) that is 
drug is to be  for distribution to patients 
dispensed)    
Medication Guide that is for  Minimum 10-point 
distribution to patients   type 
 
Other Labeling  Minimum 8-point  FDA-approved patient labeling that  Minimum 8-point type 
(e.g., labeling  type  is not for distribution to patients 
accompanying     
promotional  Any FDA-approved patient labeling  Minimum 8-point type*  
materials)  
(except a Medication Guide) that is 
for distribution to patients  
 
Medication Guide that is for  Minimum 10-point 
distribution to patients   type 
 
Old Format (21 CFR 201.80) 
Trade Labeling  No minimum  FDA-approved patient labeling that  No minimum 
and  requirement  is not for distribution to patients  requirement 
Other Labeling   
Any FDA-approved patient labeling  No minimum 
(except a Medication Guide) that is  requirement*  
for distribution to patients 
 
Medication Guide that is for  Minimum 10-point 
distribution to patients   type 
 
 
* FDA does not require, but encourages a minimum type size of 10 points for this information. 
 
 
 
 
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APPENDIX E HIGHLIGHTS AND CONTENTS FORMAT SAMPLE 
 
 
HIGHLIGHTS OF PRESCRIBING INFORMATION 
 -------------------------------CONTRAINDICATIONS------------------------------ 
These highlights do not include all the information needed to use [DRUG 
    [text]   
NAME] safely and effectively.  See  full prescribing information for 
    [text]  
[DRUG NAME]. 
     
  -----------------------WARNINGS AND PRECAUTIONS------------------------ 
[DRUG  NAME (nonproprietary name) dosage form, route of 
     [text]   
administration, controlled substance symbol] 
    [text]   
Initial U.S. Approval: [year] 
   
  ------------------------------ADVERSE REACTIONS------------------------------- 
WARNING: [SUBJECT OF WARNING]  Most common adverse reactions (incidence > x%) are [text]. 
See full prescribing information for complete boxed warning.   
   [text]  To report SUSPECTED ADVERSE REACTIONS,  contact [name of 
   [text]  manufacturer] at  [phone #] or FDA at 1-800-FDA-1088 or 
www.fda.gov/medwatch.  
   
----------------------------RECENT MAJOR CHANGES--------------------------  ------------------------------DRUG INTERACTIONS------------------------------- 

[section  (X.X)]          [m/year]     [text]    

[section  (X.X)]          [m/year] 
   [text] 
 
 
 
----------------------------INDICATIONS AND USAGE--------------------------- 
-----------------------USE IN SPECIFIC POPULATIONS------------------------ 
[DRUG NAME] is a [name of pharmacologic class] indicated for: 

   [text]   
   [text] 
 
   [text]  
   [text] 
  
 
 
See 17 for PATIENT COUNSELING INFORMATION [and FDA-
----------------------DOSAGE AND  ADMINISTRATION----------------------- 
approved patient labeling OR and Medication Guide]. 
   [text]   
   [text]                          Revised:  [m/year] 
 
 
---------------------DOSAGE FORMS AND STRENGTHS---------------------- 
   [text]    
 
_______________________________________________________________________________________________________________________________________  
FULL PRESCRIBING INFORMATION: CONTENTS*   
 
WARNING: [SUBJECT OF WARNING]  
9 DRUG ABUSE AND DEPENDENCE 
1 INDICATIONS AND USAGE  9.1  Controlled Substance 
1.1  [text]   
9.2  Abuse 
1.2  [text]  
9.3  Dependence 
2 DOSAGE AND ADMINISTRATION 
10  OVERDOSAGE  
2.1  [text]  
11 DESCRIPTION 
2.2  [text]  
12 CLINICAL PHARMACOLOGY 
3 DOSAGE FORMS AND STRENGTHS  12.1   Mechanism of Action 
4 CONTRAINDICATIONS   12.2  Pharmacodynamics 
5 WARNINGS AND PRECAUTIONS 
12.3  Pharmacokinetics  
5.1  [text]  
12.4  Microbiology  
5.2  [text]  
12.5  Pharmacogenomics 
6 ADVERSE REACTIONS  
13 NONCLINICAL TOXICOLOGY 
6.1  [text]    
  13.1   Carcinogenesis, Mutagenesis, Impairment of Fertility  
6.2  [text]   
  13.2   Animal Toxicology and/or Pharmacology  
7 DRUG INTERACTIONS  
14 CLINICAL STUDIES 
7.1  [text]  
14.1  [text]  
7.2  [text]  
14.2  [text]  
8 USE IN SPECIFIC POPULATIONS 
15 REFERENCES 
8.1  Pregnancy  
16 HOW SUPPLIED/STORAGE AND HANDLING  
8.2  Labor and Delivery  
17 PATIENT COUNSELING INFORMATION 
8.3  Nursing Mothers 
 
8.4  Pediatric Use 
*Sections or subsections omitted from  the full prescribing information are not 
8.5 Geriatric Use 
listed. 
 
 
 
 
 
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