Guidance 

 
Useful Written 

Consumer Medication 

Information (CMI) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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) 

 
July 2006 

Procedural 

   
Guidance 

 
Useful Written 

Consumer Medication 

Information (CMI) 

 
 
Additional copies are available from: 

 
Office of Training and Communication 

Division of Drug Information, HFD-240 

Center for Drug Evaluation and Research 

Food and Drug Administration 

5600 Fishers Lane 

Rockville, MD 20857 

(Tel) 301-827-4573 

http://www.fda.gov/cder/guidance/index.htm 

 
or 

 
Office of Communication, Training and 

Manufacturers Assistance, HFM-40 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

1401 Rockville Pike 

Rockville, MD 20852-1448 

 http://www.fda.gov/cber/guidelines.htm 
 
Phone: the Voice Information System at 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) 

 
July 2006 

Procedural
 
  Contains Nonbinding Recommendations 
 
 
 
 
TABLE OF CONTENTS 
 
 
I.   INTRODUCTION............................................................................................................. 1 
 
II.   BACKGROUND ............................................................................................................... 1 
 
III.   APPLYING THE ACTION PLAN CRITERIA FOR CMI.......................................... 5 
 
A.   General Considerations ................................................................................................................. 5
  
B.   Specific Recommendations for Each Action Plan Criterion ......................................................6 
 
C.   Summary.......................................................................................................................................11 
 
APPENDIX .................................................................................................................................. 13 
 
 
 
 
 
 
 
 
 
   
 
  Contains Nonbinding Recommendations 
 
 
Guidance on Useful Written  

 1
 
Consumer Medication Information (CMI)   
 
 
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 the approach 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 individuals or organizations (e.g., pharmacies, private 
vendors, healthcare associations) in developing useful written consumer medication information 
(CMI). CMI is written information about prescription drugs developed by organizations or 
individuals other than a drugs manufacturer that is intended for distribution to consumers at the 
time of drug dispensing.  Since neither FDA nor a drugs manufacturer reviews or approves 
CMI, FDA recommends that the developers of written medication information use the guidance 
contained in this document to help ensure that their CMI is useful to consumers. 
 
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.  
 
 
II.  BACKGROUND 
 
Traditionally, FDA has believed that people are able to make better decisions about their 
healthcare and better use of the prescription medications available to them when they are well 
informed about the medications they take.  Access to useful written information about 
prescription medications is important to ensuring appropriate use of these products.  Over the 
years, FDA has undertaken a number of efforts to help ensure that consumers receive useful, 
______________________ 
 
1  This guidance has been prepared by the Office of Drug Safety in the Center for Drug Evaluation and Research  
(CDER), in consultation with the Center for Biologics Evaluation and Research, at the Food and Drug  
Administration. 
 
  1 
 Contains Nonbinding Recommendations 
 
 
reader-friendly written information regarding their prescription medications.  These efforts are 
described briefly here. 
 
Since 1968, FDA regulations have required that patient package inserts, written specifically for 
patients, be distributed to patients when certain prescription drugs, or classes of prescription 
drugs, are dispensed (see 21 CFR 310.501 for oral contraceptives and 310.515 for estrogens).  In 
the 1970s, however, FDA began evaluating the general usefulness of patient labeling for 
prescription drugs, resulting in a series of regulatory steps to help ensure the availability of 
useful written consumer information: 
 
	   In 1979, FDA proposed regulations that would require written patient information for all 
prescription drugs (44 FR 40016; July 6, 1979).   
	   In 1980, FDA finalized those regulations. They established requirements and procedures 
for the preparation and distribution of manufacturer-prepared and FDA-approved patient 
labeling for a limited number of prescription drugs (45 FR 60754; September 12, 1980).  
	   In 1982, FDA revoked those regulations, in part based on assurances by pharmaceutical 
manufacturers, healthcare professional associations, and private-sector providers of 
written medication information for patients that the goals of the final rule would be met 
more effectively and with greater innovation without regulation (47 FR 39147, 
September 7, 1982).  
FDA committed to monitor the progress of this private-sector effort.  Unfortunately, periodic 
FDA surveys showed that, although the distribution of written prescription drug information 
increased, the usefulness of the information was highly variable.  As a result: 
	   In 1995, FDA proposed a regulation entitled Prescription Drug Product Labeling: 
Medication Guide Requirements (60 FR 44182; August 24, 1995), designed to set 
specific distribution and quality goals and time frames for distributing written 
information.  
The regulation had the following goals: 
-  By the year 2000, 75 percent of people receiving new prescriptions would receive 
useful written patient information with their prescriptions. 
 
-  By 2006, 95 percent of people receiving new prescriptions would receive useful 
written patient information with their prescriptions.   
 
The proposed rule would also require manufacturers to prepare and distribute Medication Guides 
for a limited number of prescription drug products that posed a serious and significant public 
  2 
 Contains Nonbinding Recommendations 
 
 
health concern. In addition, the proposed rule described criteria for usefulness to permit 
evaluation of whether the information met the target goals.2    
 
	   On August 6, 1996, as FDA was reviewing the public comments on the 1995 proposed 
rule, Public Law 104-180 was enacted.3    
 
This law adopted goals and time frames consistent with the 1995 proposed rule.  The 
legislation also established a voluntary private-sector process through which a committee of 
interested stakeholders would develop a long-range comprehensive action plan to achieve the 
goals specified in the statute.  The law also required the Secretary of the U. S. Department of 
Health and Human Services to evaluate the private sectors progress toward meeting the 
goals in the law and, if the goals were not met, to seek public comment on other initiatives to 
meet the goals.  The law prohibited FDA from taking further regulatory steps specifying a 
uniform content or format for written information voluntarily provided to consumers about 
prescription drugs if private-sector initiatives met the goals of the plan within the specified 
time frames.   
 
	   In 1996, after Public Law 104-180 was enacted, a Steering Committee was created.  
The Steering Committee, consisting of healthcare professionals, consumer organizations, 
voluntary health agencies, pharmaceutical manufacturers, prescription drug wholesalers, drug 
information database companies, CMI developers, and others, developed a report entitled 
Action Plan for the Provision of Useful Prescription Medicine Information (the Action 
Plan).4  The Action Plan delineated criteria for evaluating whether a particular piece of 
written medication information is useful to consumers.  The Action Plan endorsed the 
elements specified in Public Law 104-180 for defining the usefulness of medication 
information.   Specifically, the Action Plan stated materials should be:  
- 	 scientifically accurate 
- 	 unbiased in content and tone 
- 	 sufficiently specific and comprehensive  
______________________ 
 
2  FDA also specified  that the usefulness of written patient information  would be  evaluated based on  scientific 
accuracy, consistency with a  standard format, nonpromotional tone and content, specificity, comprehensiveness,  
understandable language, and  legibility. 
 
3 Public Law  104-180, Title VI, Sec 601 Effective Medication  Guides, 110  Stat 1593  (1996). 
 
4 Steering Committee for the  Collaborative Development of a Long-Range Action Plan  for the Provision  of Useful  
Prescription Medicine  Information,  unpublished report submitted to The Honorable Donna  E. Shalala, Secretary of 
the U. S.  Department of Health and Human Services, December 1996, available on the Internet at 
http://www.fda.gov/cder/offices/ods/keystone.pdf. Secretary Shalala accepted the Action Plan  by letter dated 
January 13, 1997. 
 
  3 
 Contains Nonbinding Recommendations 
 
 
-  presented in an understandable and legible format that is readily comprehensible to 
consumers 
- 	 timely and up-to-date 
-  useful, that is, enables the consumer to use the medicine properly and appropriately, 
receive the maximum benefit, and avoid harm  
 
	   In 1998, FDA contracted with the National Association of Boards of Pharmacy (NABP) 
to conduct a CMI assessment to determine progress toward meeting the stated goals of 
Public Law 104-180. 
 
The NABP performed a pilot study to test the usefulness of the CMI being developed. The 
NABP also conducted a national study to assess the extent to which the year 2000 goals 
specified in the law had been achieved. The results of the study were announced in 2002.  
On average, 89 percent of the patients in the study received some form of written medication 
information.  However, the average usefulness of the information was only about 50 percent.5   
 
	   On July 17, 2002, the FDA Drug Safety and Risk Management Advisory Committee 
(Advisory Committee) met to review the study results and public comments. 
 
The Advisory Committee recommended that FDA take a more active role in advising and 
encouraging the private sector to meet the next target goal set for year 2006.6    
 
In response to that recommendation, the Agency met with various groups, held a public meeting 
in 2003 (see www.fda.gov/cder/offices/ods/writtenPrescripinfo.htm), and was asked to provide 
clarification on how the Action Plan should be interpreted and implemented.  This guidance is 
part of FDAs efforts to assist developers of CMI.  This guidance provides recommendations to 
developers of CMI regarding how best to evaluate current CMI and develop future CMI to help 
ensure that all CMI meets the usefulness criteria provided in the Action Plan.  FDA views the 
criteria and components described in the Action Plan as the minimum appropriate characteristics 
of useful CMI. Throughout this guidance, in providing recommendations about the Action Plan 
criteria, FDA uses the wording of the Action Plan as much as possible.   
 
______________________ 
 
5 Svarstad, B.L. and J.K. Mount, Evaluation  of Written Prescription Information Provided in Community 
Pharmacies, 2001, final report to the U.S.  Department of Health and Human Services and the Food and Drug  
Administration, December 2001, available on the Internet at  
http://www.fda.gov/cder/reports/prescriptioninfo/default.htm. 
 
6A transcript  of FDA's Drug Safety and Risk  Management Advisory Committee meeting on July 17, 2002, is  
available on the Internet at  http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3874T1.htm. 
 
  4 
 Contains Nonbinding Recommendations 
 
 
 
III.   APPLYING THE ACTION PLAN CRITERIA FOR CMI 
 
A.  General Considerations 
 
As discussed above, by 2006, 95 percent of people who receive new prescriptions should receive 
useful written patient information with their prescriptions.  To determine whether CMI 
developers have met that goal, FDA will evaluate CMI against the Action Plans criteria for 
usefulness. This guidance is intended to assist developers of CMI in meeting the 2006 goal by 
providing specific recommendations for implementing the Action Plan criteria. 
 
CMI that adheres to the Action Plan criteria, as accepted by the Secretary, for a specific 
prescription drug will be considered useful when (1) information in generalized CMI about the 
use of or indication for use of the drug is consistent with the most recent version of the 
manufacturers professional labeling or package insert (PI) (see 21 CFR 201.56 and 201.57)7,8  
and (2) it includes the components suggested in the Action Plan and substantially conforms to 
the formatting suggestions made in the Action Plan.  Specifically, written CMI should be:  
 
	   scientifically accurate 
	   unbiased in content and tone 
	   sufficiently specific and comprehensive  
	   presented in an understandable and legible format that is readily comprehensible to 
consumers  
	   timely and up-to-date  
	   useful 
 
Critical criteria, components, and formatting suggestions are in Chapter 3 (Guidelines for Useful 
Prescription Medication Information) and Appendix G (Specific Language and Format 
Guidelines, with Samples) of the Action Plan. This guidance provides FDAs recommendations 
to the private sector for implementing the Action Plan criteria.   
 
The eight categories listed in the following table were developed by an expert panel, 
subcontracted by NABP for FDAs evaluation of CMI in 2001, by combining the Action Plan 
criteria and components. FDA believes that this list provides the factors for determining whether 
written medication information is useful under the Action Plan.  Written information that 
______________________ 
 
7 FDA-approved  drug  products and labeling  can be found on the Internet at  
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. However, this Web site does not list all FDA-
approved  products and labeling.  We are working to make  all approved labeling available soon. 
 
8 Consistent with the Action Plan and acceptance by the Secretary, information beyond the FDA-approved labeling, 
such  as patient-specific indications for use from  scientific literature or provided by  the prescriber, is appropriate in 
customized patient information.  FDA recommends that  the source of such information be included in CMI. 
 
  5 
 Contains Nonbinding Recommendations 
 
 
substantially satisfies each Action Plan criterion listed in the table will be deemed useful and will 
count toward the quantitative goals of Section 601 of Title VI of Public Law 104-180.  
 
Action Plan Criteria for Defining Useful Information  
 
   
Criterion   Description  
1   Drug names, indications for use, and how to monitor for improvement  
2   Contraindications and what to do if they  apply  
3   Specific directions about how to use and store the medicine, and overdose 
information  
4   Specific precautions and warnings about the medicine  
5   Symptoms of serious or frequent possible adverse reactions and what to do  
6   Certain general information, including encouraging patients to 
communicate with healthcare professionals, and disclaimer statements  
7   Information that is scientifically accurate, unbiased in tone and content, 
and up-to-date  
8   Information in an understandable and legible format that is readily  
comprehensible to consumers 
 
 
 B.  Specific Recommendations for Each Action Plan Criterion  
 
Criterion 1: Drug Name, Indications for Use, and How to Monitor for Improvement 
 
We recommend that the following information be included in the CMI to satisfy Criterion 1:   
 
	   Established or proper name and brand name  (e.g., the trademark or proprietary name) of 
the drug. FDA recommends also including the phonetic spelling of the brand name,9 or 
the established name if a brand name does not exist. 
      
	   All FDA-approved indications listed in the PI for the medication.  Information on 
unapproved indications should only be included in CMI customized for individual 
patients. 
 
______________________ 
 
9 The Action Plan contained an error in  reference to established name and  brand name. All  marketed products have 
an established  name (also known as the generic name), while not all products have a brand  name. Therefore, if a 
brand name does not exist, the phonetic spelling of the established name  would be used.  
 
 
  6 
 Contains Nonbinding Recommendations 
 
 
	   Information regarding how to monitor the effectiveness of the treatment by correctly 
interpreting physical reactions to the medicine, if this information is in the PI. This would 
include, for example, informing patients about when to call their healthcare provider if  
they do not notice signs of improvement. 
 
Criterion 2: Contraindications and What to Do If They Apply 
 
We recommend that the following information be included in the CMI to satisfy Criterion 2: 
 
	   Information about circumstances in which the medication should not be used for its 
labeled indication. Include all contraindications listed in the PI. 
 
	   Directions about what to do if any of the contraindications apply to the patient, such as 
contacting the healthcare provider before taking the medicine or discussing with him or 
her situations that would warrant discontinuing use of the medication.  Include a general 
statement such as, Talk to your healthcare provider before taking this medicine if you 
have any of these conditions. 
 
	   Information on any contraindication that could result in serious injury or death if it is 
disregarded. 
 
	   A statement of precaution about any circumstances (such as past or current medical 
conditions or use of other medications, vitamins, or supplements) in which the use of the 
medication could lead to serious injury or death.  
 
Criterion 3:  Specific Directions About How to Use and Store the Medicine and Information 
About Overdose 
 
We recommend that the following elements be addressed to satisfy Criterion 3: 
 
	   The CMI should be considered a stand-alone document in meeting this criterion.  The 
label and packaging of the dispensed medication may also contain such information (e.g., 
name, strength, dosage, brief directions for use), but should not be considered as part of 
CMI. 
 
	   The Action Plan recommends that information regarding the usual dosing instructions 
be included. To avoid confusion between the usual dosing instructions and the prescribed 
dose, FDA suggests that the CMI refer the patient to the prescription label for specific 
dosing instructions.  A statement should be included in the CMI stressing that it is 
important to follow the dosing instructions provided by the patients healthcare provider, 
which is usually found on the prescription label for the medicine. 
 
	   If detailed instructions describing how to administer the medication (instructions for use) 
are included in the manufacturers patient  labeling for the product (for example, 
instructions for inhalers, injections, and patches), include a statement to alert the patient 
to read the instructions for use contained in the package. 
  7 
 Contains Nonbinding Recommendations 
 
 
 
	   State the route of administration.  Examples of information about the route of 
administration are skin use only if a patch and do not swallow if a suppository. 
 
	   If specified in the PI, include information on how to use the medication, such as whether 
to take it with or without food or water, times of day to take the medication, and any 
other instructions, for example, statements such as (1) Do not chew, (2) Do not split or 
crush, and (3) Do not lie down for 30 minutes after taking this medicine. 
 
	   Describe what patients can do if they miss a scheduled dose, if this information is in the 
PI. 
 
	   State what to do in case of an overdose. If overdose is a significant issue for a particular 
medication, include text describing signs of overdose so that patients can recognize the 
symptoms.  In all cases, we recommend that symptoms of overdose be directly followed 
by instructions for what to do should these signs or symptoms occur, such as calling a 
poison control center, the doctor, or other emergency telephone number. 
 
	   Include storage instructions. 
 
Criterion 4: Specific Precautions and Warnings  
 
If the PI contains any boxed warnings that relate to important knowledge the consumer should 
have or actions the consumer should take, we recommend that a prominently displayed statement 
which is consistent with or derived from the boxed warnings be included in the CMI.  FDA 
believes that most boxed warnings have information that is relevant to the consumer. 
 
We recommend that the CMI include all information stated in the PI regarding what precautions 
the patient should take while using the drug to avoid serious situations.  For example, the 
following information should be included, if relevant to the medication: 
 
	   Drugs to avoid because of drug-drug interactions.  FDA notes that some drugs have few 
labeled drug-drug interactions, while other drugs list numerous interactions.  We do not 
recommend that CMI list every possible interaction.  We do recommend, at minimum,  
including all drugs listed in the Contraindications section of the PI, and we encourage 
including interactions listed in the Warnings and Precautions sections of the PI. If there 
are interactions in the PI that will not be included in CMI, we recommend that a 
consumer-friendly statement appear in CMI explaining that the list is not complete, 
telling patients that other medicines they are taking may interact with the product, and 
encouraging patients to keep a list of all the medicines they take to share it with their 
doctor or pharmacist.  We also recommend that if specific drugs are listed as interactions 
in CMI, both generic and trade names be included. 
 
	   Foods and other substances (e.g., dietary supplements) to avoid because of the potential 
for interactions. Since the Action Plan was written, there has been increased awareness 
  8 
 Contains Nonbinding Recommendations 
 
 
of dietary supplement interactions with medications.  If such interactions are included in 
the PI, include them in the CMI in the same way as drug and food interactions.  
 
	   A description of the risks, if any, to the patient of developing a tolerance to or 
dependence on the drug product. Such risks would be described in the PI.  Any signs and 
symptoms of tolerance or dependence should be stated in terms that the patient would be 
able to understand to recognize them.  
 
	   Patient activities and behavior to avoid.  Examples of such activities include smoking 
tobacco, drinking alcohol, being exposed to the sun, or driving a vehicle or operating 
dangerous machinery.   
 
	   Any risks to the mother and the fetus or the infant from use of the drug during pregnancy, 
labor, or breast-feeding. If the risks are unknown, include a statement such as, Talk to 
your doctor if you are pregnant or breast-feeding.   
     
	   Specific risks to identifiable patient populations, such as children, elderly patients, people 
with compromised immune systems, or people with impaired kidney or liver functioning, 
if such information is in the PI.  Provide enough information for the consumer to 
understand the importance of the hazard described. 
 
Criterion 5: Symptoms of Serious or Frequent Possible Adverse Reactions and What to Do  
 
Under the Action Plan, CMI is not expected to contain a full listing of all possible side effects.  
Because the most serious potential adverse reactions will most likely appear in the Warnings and 
Precautions sections of the PI, we recommend that this information also be included in CMI.  In 
addition, we recommend that CMI include a list of the symptoms of the most frequently 
occurring (common) adverse reactions.  
 
We recommend including a statement telling patients that the side effects given are not a 
complete list and instructing them to ask their doctor or pharmacist for more information. 
 
Criterion 6:  Certain General Information, Including Encouraging Patients to Communicate 
with Healthcare Professionals, and Disclaimers 
 
We recommend that certain general information be contained in all CMI: 
 
	   A statement that the medicine should only be used by the patient for whom it is 
prescribed and should not be given to other people. 
 
	   The name of the publisher of the CMI. 
 
	   The date that the CMI was published or the date of the most recent revision or review for 
adequacy and accuracy of content. 
 
  9 
 Contains Nonbinding Recommendations 
 
 
	   A disclaimer stating that the CMI is a summary and does not contain all possible 
information about the medicine. 
 
	   A statement encouraging discussion with a healthcare professional about the prescription 
medicine.  A statement that the healthcare professional who prescribed the medicine has 
additional information about the medicine as well as about the patients specific health 
needs, and that the healthcare professional can provide this information to the patient and 
answer the patients questions.  An example of a statement that covers both 
recommendations could be: This leaflet summarizes the most important information 
about <insert medication name>. If you would like more information, talk with your 
doctor. 
 
Criterion 7: Information That Is Scientifically Accurate, Unbiased in Tone and Content, and 
Up-to-Date 
 
Scientific accuracy is an essential characteristic of CMI.  The entire CMI will be assessed for 
scientific accuracy and bias.  The information in the CMI about the use of or indication for use of 
the drug should be consistent with or derived from the PI, unless the CMI is customized for a 
specific patient. FDA-approved indications could also be listed with the customized information. 
 
The text of the CMI should be unbiased in content and tone and should meet the accepted 
standards of scientific literature.  That is, the text should be explanatory; neutral; without 
comparative adjectives, untruthful claims about the benefit of a product, or hyperbole; and 
distinguished from any promotional or other information provided to the patient. 
 
CMI should not promote a specific brand, manufacturer, or distributor for the purpose of 
economic gain.  
 
Criterion 8: Information in an Understandable and Legible Format That Is Readily 
Comprehensible to Consumers  
 
To be useful, CMI should be written in wording that is understandable.  To meet the Action Plan 
criterion of being understandable, we suggest that CMI be provided at the sixth to eighth grade 
reading level. We encourage using plain language and looking at the message from the readers 
point of view. 
 
CMI should adhere to the criteria, components, and formatting suggestions in Chapter 3 
(Guidelines for Useful Prescription Medication Information) and Appendix G (Specific 
Language and Format Guidelines, with Samples) of the Action Plan, which reflect widely 
recognized standards used by designers and publishers of written information to ensure that the 
materials are legible and readable. We recommend that CMI be designed to ensure the 
prominence of important information.  It is helpful to use formats that distinguish between the 
degree of seriousness of cautions or warnings.  Information should be written clearly and 
concisely, and complex terms should be avoided.  Polysyllabic words could be replaced by 
shorter, simpler words (e.g., harmful rather than detrimental), even if it takes several words to 
get across a concept that can be expressed in a single, more complex term. 
  10 
 Contains Nonbinding Recommendations 
 
 
 
We recommend the following formatting: 
 
	   Use 10-point or larger type size. 
  
	   Do not use ornate typefaces and italics.  Choose a bolder type over a thin version of the 
same style. 
  
	   Use upper- and lower-case lettering, not all capitals. 
 
	   Use bold-face type or a box to call attention to important information, rather than 
highlighting or underlining. 
 
	   Provide adequate space between letters, lines, and paragraphs.  We suggest that text 
generally have no more than 3 kerning (space between letters).  With 10-point type, 12-
point leading (space between lines) is recommended (at least 2.2 millimeters).  Provide 
adequate space between paragraphs and space above and below headings.  
 
	   Do not use a line length that is too long.  In 10-point or 12-point type, optimal line length 
is approximately 40 letters long. 
 
	   Select text color and paper that give a strong contrast.  Black, dark blue, or brown ink on 
white or pale yellow uncoated paper provides the best contrast.  We suggest that other 
combinations be avoided. 
 
	   Use short paragraphs and bullets where possible. 
 
C.  S	 ummary 
 
The components of useful information identified in the Action Plan are meant to be useful as a 
total package. We suggest that the information be provided in the following order: 
 
1.   Personalized information in a box (if customized for individual patients) 
2.   Established name and brand name  
3.   What the medicine is used for 
4.   Do not take this medicine if you are... 
5.   How to take the medicine 
6.   Side effects include ... 
7.   General information 
 
This list is not the only appropriate headings or order in which the headings should appear.  
Moreover, information pertaining to each Action  Plan criterion need not be organized under the 
above-specified individual headings; they can be combined as appropriate. 
 
The Appendix contains examples of CMI that follow the recommendations in this guidance. 
These examples are not to be construed as required formats.  Since many formats are consistent 
  11 
 Contains Nonbinding Recommendations 
 
 
with the recommendations for usefulness, three possible formats for the same drug are 
illustrated. 
 
 
 
 
 
 
 
  12 
 Contains Nonbinding Recommendations 
 
 
APPENDIX 
 
 
Prescription Medicine Information 
 
Cefaclor   
for Oral Suspension  [sef-ah-klor]  
Why is Cefaclor for Oral Suspension prescribed? 
Cefaclor is used to treat infections caused by certain bacteria.  These infections include middle ear, 

bladder, and skin infections, as well as strep throat and pneumonia.  Cefaclor works by killing certain 

bacteria or preventing them from growing.  

 
Cefaclor is in a class of medicines known as cephalosporin antibiotics.   

These medicines are sometimes prescribed for uses other than those listed in this leaflet.  If you have any
  
questions please call your healthcare provider. 

 
 
Before Taking Your Medicine 
Do not take Cefaclor if you are allergic to any cephalosporin antibiotics. Allergic reactions to Cefaclor 
can cause death. 
 
Talk with your healthcare provider if you have any of the following conditions. This medicine may 
not be right for you, if you: 
 	  have diabetes.  Cefaclor can interfere with the urine test you may be using to test for sugar. 
	   have kidney  disease. 
	   have colitis or other stomach or intestine problems. 
	   are allergic to penicillin or other antibiotic medicines.  
	   are pregnant or nursing.    
 
 
While You Are Taking Your Medicine 
Take Cefaclor exactly as prescribed.  Continue taking Cefaclor even if you feel better.  If you stop  
taking Cefaclor too soon, the bacteria can grow back and you may get sick again with the same infection. 
	   Take Cefaclor by mouth, with or without food.  
	   If you miss taking a dose of Cefaclor, take it as soon as you remember. 
	   If it is almost time for your next dose, skip the missed dose and take your next dose as scheduled. 
	   Do not take double your prescribed dose. 
	   If you think that someone may have taken more than the prescribed dose of this medicine, call 
your poison control center or emergency room right away. 
	   Shake the bottle well each time before taking this medicine.   
	   Keep Cefaclor for Oral Suspension in the refrigerator.  Throw away any unused Cefaclor after the 
expiration date. 
 
 
  13 
 Contains Nonbinding Recommendations 
 
 
 
Prescription Medicine Information 
Possible side effects 
 
The most common side effects are mild upset stomach, diarrhea, and rash. Call your healthcare 
provider if these side effects bother you or do not go away.  
 
Call your healthcare provider right away if the following side effects occur:  
   swelling of the throat or trouble breathing  
   hives, itching, and rash  
   severe or bloody  diarrhea  
   stomach area pain  
   tiredness or faintness (that lasts after taking this medicine for 24 hours)  
   fever (that lasts after taking this medicine for 24 hours)  
   joint aches or stiffness (that lasts after taking this medicine for 24 hours)  
 
 
 
 
 
General Information 
   This medicine was prescribed for your condition. 
   Do not use it for another condition or give the medicine to others. 
 
This leaflet provides a summary of information about Cefaclor and does not contain all possible 
information about this medicine.  If you have any questions or concerns, or want more 
information about Cefaclor, call your healthcare provider or pharmacist.  Your pharmacist also 
has a longer leaflet about Cefaclor that is written for health professionals that you can ask to read. 
 
[Name of publisher and date of most recent publication or revision] 
  14 
 Contains Nonbinding Recommendations 
 
 
 
Prescription Medicine Information 
Questions and Answers About 
 
Cefaclor   
for Oral Suspension  [sef-ah-klor] 
 
What is Cefaclor for Oral Suspension? 
Cefaclor is used to treat infections caused by certain bacteria. These infections include middle ear, 
bladder, and skin infections, as well as strep throat and pneumonia. Cefaclor works by killing certain 
bacteria or preventing them from growing. Cefaclor is in a class of medicines known as cephalosporin 
antibiotics. These medicines are sometimes prescribed for uses other than those listed in this leaflet. If 
you have any  questions please call your healthcare provider.   
 
Who should not take Cefaclor for Oral Suspension? 

Do not take Cefaclor if you are allergic to other cephalosporin-class antibiotics. Allergic reactions to 

Cefaclor can cause death. 

 
Talk with your healthcare provider if you have any of the following conditions. This medicine may 

not be right for you, if you:   

 	  have kidney  disease 
 	  have colitis or other stomach or intestine problems  
 	  are pregnant or breastfeeding   
 	  are a diabetic and are checking your urine for sugar (Cefaclor can interfere with the urine test 
you may be using)  
 
How should I take Cefaclor for Oral Suspension? 
 	  Follow your healthcare providers advice about how to take Cefaclor. Continue taking Cefaclor 
even if you feel better. Be sure to take all of the medicine for the length of time prescribed for 
you. If you stop taking  your medicine too soon, the bacteria can grow back and you may get sick 
again with the same infection.  
 	  Take Cefaclor by mouth, with or without food.  
 	  Shake your bottle well every  time before taking the medicine. 
 	  If you miss taking a dose of Cefaclor, take it as soon as you remember.  If it is almost time for your  
next dose, skip the missed dose and take your medicine as scheduled. Do not take double your  
prescribed dose.  
 	  If you think that someone may have taken more than the prescribed dose of this medicine, call your 
poison control center or emergency room right away. 
 
 
 
  15 
 Contains Nonbinding Recommendations 
 
 
 
Prescription Medicine Information 
 
What are the possible side effects of Cefaclor for Oral Suspension? 
The most common side effects are mild upset stomach, diarrhea, and rash. Call your healthcare provider if 
these side effects bother you or do not go away. 
Call your healthcare provider right away if the following side effects occur:  
   swelling of the throat or trouble breathing  
   hives, itching, and rash 
   severe or bloody  diarrhea 
   stomach area pain 
   tiredness or faintness (that lasts after taking this medicine for 24 hours) 
   fever (that lasts after taking this medicine for 24 hours)  
   joint aches or stiffness (that lasts after taking this medicine for 24 hours) 
 
How should I store Cefaclor for Oral Suspension? 
   Keep Cefaclor for Oral Suspension in the refrigerator. 
   Throw away  any  unused Cefaclor after the expiration date.  
__________________   
 
This medicine was prescribed for your particular condition.  Do not use it for another condition or give 
the medicine to others. 
 
This leaflet provides a summary of information about Cefaclor and does not contain all possible 
information about this drug.  If you have any  questions or concerns, or want more information about 
Cefaclor, call your healthcare provider or pharmacist. Your pharmacist also has a longer leaflet about 
Cefaclor that is written for health professionals that you can ask to read. 
 
 
[Name of publisher and date of most recent publication or revision] 
  16 
 Contains Nonbinding Recommendations 
 
 
 
Prescription Drug Information 
Cefaclor 
for Oral Suspension  
 
 
Summary 
Cefaclor (pronounced sef-ah-klor) is used to treat infections caused by certain bacteria. You should not 

take Cefaclor if you are allergic to similar antibiotics. Allergic reactions to Cefaclor can cause death. If 

you have trouble breathing, swelling of the throat, rash, severe diarrhea, or stomach area pain, call your 

healthcare provider right away or get medical help. 

Take Cefaclor for the length of time prescribed by  your healthcare provider, even if you feel better. 

Shake your bottle well every  time before taking Cefaclor. 

 
Uses   	  have diabetes. Cefaclor can  
Cefaclor is used to treat  interfere with the urine test 
infections caused by certain  you may be using to test for 
bacteria. These infections  sugar. 
include middle ear, bladder, and   	  have kidney  disease. 
skin infections, as well as strep   	  have colitis or other 
throat and pneumonia. Cefaclor  stomach or intestine 
works by killing certain bacteria  problems. 
or preventing them from    	  are pregnant or are breast-
growing.  feeding. 
   	  are allergic to penicillin or 
Cefaclor is in a class of  other antibiotic medicines.  
medicines known as   
cephalosporin antibiotics. These  Proper Use 
medicines are sometimes 
 	  Follow your healthcare 
prescribed for uses other than 
providers advice about how 
those listed in this leaflet. If you 
to take Cefaclor. Continue 
have any questions please call 
taking Cefaclor even if you  
your doctor or other prescriber. 
feel better. Be sure to take 
 
all of the medicine 
General Cautions 
prescribed for you. If you 
 	  Do not take Cefaclor if  stop taking  your medicine 
you are allergic to other  too soon, the bacteria can 
cephalosporin-class  grow back and you may get 
antibiotics. Allergic  sick again with the same  
reactions to Cefaclor can  infection. 
cause death. 
This medicine may not be for 
you. Check with your 
healthcare provider if you: 
  17 
 Contains Nonbinding Recommendations 
 
 
Prescription Drug   
Each teaspoon (5 mL) of 
Information 
Cefaclor for Oral Suspension 
 
contains 125, 250, or 375 mg  of 
 	  Shake your bottle well  Cefaclor monohydrate and is 
every time before taking  pink in color.  
this medicine.   
 	  If you miss taking a dose of   If you think that someone may  
Cefaclor, take it as soon as  have taken more than the 
you remember.  However, if  prescribed dose of this 
it is almost time for your  medicine, call your local poison 
next dose, skip the missed  control center or emergency 
dose and take your medicine  room right away. This medicine 
as scheduled. Do not take  was prescribed for your 
double your prescribed  condition. Do not use it for 
dose.   another condition or give it to 
  others. 
Possible Side Effects   
This leaflet provides a summary  
The most common side effects 
of information about Cefaclor.  
are mild upset stomach, 
If you have any questions or 
diarrhea, and rash. Call your 
concerns, or want more 
healthcare provider if these side 
information about Cefaclor, call 
effects continue or bother you.  
your healthcare provider or  
 
pharmacist. Your pharmacist 
Call your healthcare provider 
also has a longer leaflet about 
right away if the following 
Cefaclor that is written for 
side effects occur:  
health professionals that you 
 	  Swelling of the throat or 
can ask to read. 
trouble breathing 
 
 	  Hives, itching, and rash 
[Name of publisher and date of  most recent 
 	  Severe or bloody  diarrhea  publication or revision]  
 	  Stomach pain   
 	  Tiredness or faintness (that 
 
lasts after taking this 
medicine for 24 hours) 
 	  Fever (that lasts after taking  
this medicine for 24 hours)  
 	  Joint aches or stiffness (that 
lasts after taking this 
medicine for 24 hours) 
 
Storage 
 	  Keep Cefaclor for Oral 
Suspension in the 
refrigerator.  
 	  Throw away any unused 
portion after the expiration 
date.  
______________________  
 
 
18