Recommended Statement for Over-
the-Counter Aspirin-Containing 
Drug Products Labeled With 
Cardiovascular Related Imagery 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
November 2017 
Compliance
 
   
Recommended Statement for Over-
the-Counter Aspirin-Containing 
Drug Products Labeled With 
Cardiovascular Related Imagery 
 
Guidance for Industry 
 
 
 
 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
November 2017  
Compliance 
  Contains Nonbinding Recommendations 
 
 
   
TABLE OF CONTENTS 
 
 
I.  INTRODUCTIONAND SCOPE...................................................................................... 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  DISCUSSION AND POLICY .......................................................................................... 2 
 
 
 
 
 
  i  Contains Nonbinding Recommendations 
 
 
Recommended Statement for Over-the-Counter Aspirin-
Containing Drug Products Labeled With Cardiovascular 
Related Imagery 
1
Guidance for Industry  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page. 
 
 
 
I.  INTRODUCTION AND SCOPE 
 
This guidance applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination 
with an antacid, labeled with cardiovascular related imagery marketed under the Tentative Final 
Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug 
Products for OTC Human Use (53 FR 46204, November 16, 1988).2  FDA is aware that some 
over-the-counter (OTC) aspirin drug products are marketed with cardiovascular related images, 
such as heart symbols, which suggest or imply that the products are intended for use in the 
prevention of cardiovascular events.  Secondary prevention of cardiovascular events is permitted 
as an indication for aspirin in professional labeling (21 CFR 343.80).  This guidance is intended 
to promote the safe use of OTC aspirin drug products by encouraging drug manufacturers, 
packagers, and labelers marketing aspirin drug products with cardiovascular related imagery to 
include a statement that reminds consumers to talk to their doctor or other healthcare provider 
before using aspirin for the professional indication of secondary prevention of cardiovascular 
events.    
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys 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 
 
Aspirin is a common active ingredient in many prescription and OTC drug products.  Most OTC 
aspirin drug products are currently marketed pursuant to the TFM for IAAA Drug Products (53 
                                                 
1 This guidance has been prepared by the Office of Unapproved Drugs and Labeling Compliance in the Center for 
Drug Evaluation and Research (CDER) at the Food and Drug Administration. 
2 See https://www.gpo.gov/fdsys/pkg/FR-1988-11-16/pdf/FR-1988-11-16.pdf. 
  Contains Nonbinding Recommendations 
 
 
FR 46206, November 16, 1988) for the temporary relief of minor aches and pains associated 
with a cold, headache, backache, toothache, premenstrual and menstrual cramps; minor pain of 
arthritis; and reduction in fever.2  
 
In addition to the OTC conditions of use in the IAAA TFM, FDA regulations at  343.80 also 
contain professional labeling about cardiovascular uses of aspirin directed at healthcare 
practitioners (63 FR 56802, October 23, 1998).  The cardiovascular indications for aspirin under 
professional labeling include reducing the risk of a second heart attack or stroke in patients who 
have already experienced a cardiovascular or cerebrovascular event or for patients with existing 
coronary artery disease such as angina or a history of a coronary bypass or coronary angioplasty.  
However, such long-term aspirin therapy has a number of side effects, such as stomach bleeding, 
bleeding in the brain, kidney failure, and other kinds of strokes. 
 
In the IAAA TFM, FDA proposed a labeling statement recommending that consumers consult a 
physician about the professional indications of aspirin, because of the potential side effects of 
long-term aspirin therapy (53 FR 46204, November 16, 1988).2   
 
In addition, FDA published a proposed rule on October 20, 1993, that would require OTC drug 
products that contain aspirin, buffered aspirin, or aspirin in combination with an antacid to bear a 
statement advising consumers to consult a physician before taking these products for 
cardiovascular uses (58 FR 54224, October 20, 1993).3  However, this proposed rule has not 
been finalized. 
 
  
  III.  DISCUSSION AND POLICY 
 
After publication of the professional labeling regulation for aspirin, some OTC aspirin labels4  
were modified to include cardiovascular related imagery (e.g., heart image, electrocardiography 
graphic, stethoscope around a heart image).  However, the final rule for IAAA products at  
343.80 authorizes labeling for cardiovascular events only in professional labeling directed to 
healthcare professionals. 
 
Because of the potential side effects associated with long-term aspirin therapy, FDA 
recommends that any cardiovascular related imagery on OTC aspirin labels be accompanied by a 
statement that reminds consumers to talk to their doctor or other healthcare provider before using 
aspirin for the professional indication of secondary prevention of cardiovascular events.  More 
specifically, FDA does not intend to take action against manufacturers of single-ingredient 
aspirin, buffered aspirin, and aspirin in combination with an antacid, marketed pursuant to the 
TFM for IAAA Drug Products because the product label includes cardiovascular related imagery 
such as the heart image, if the label also includes the following statement: 
 
Talk to your doctor or other healthcare provider before using this product for your heart. 
                                                 
3 See https://cdn.loc.gov/service/ll/fedreg/fr058/fr058201/fr058201.pdf.  
4 In this guidance, the term label means the written, printed, and graphic matter upon the immediate container and 
upon the outside container or wrapper of the retail package of an OTC aspirin drug product.  See section 201(k) of 
the Federal Food, Drug, and Cosmetic Act.   
  2  Contains Nonbinding Recommendations 
 
 
 
This recommended statement should appear in reasonable proximity to the cardiovascular related 
imagery and with similar prominence in at least 6-point type size font on the principal display 
panel (PDP).   
  
This guidance does not address alternative language, other health imagery, or other 
cardiovascular claims included on consumer directed label or labeling which may otherwise 
misbrand the product.   
 
  3