• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Label Format Preference (Study B)

SUMMARY: On February 27, 1997, the Food and Drug Administration (FDA) issued a proposed rule to establish a standardized, easy to read format for the labeling of over-the-counter (OTC) drug products (62 FR 9024). As part of that rulemaking proceeding, the agency has collected data under a study entitled "Over-the-Counter (OTC) Label Format Preference," also known as "Study B". In Study B (OTC Label Format Preference), consumers were invited to view examples and variations of current OTC label designs. Respondents were asked to indicate their preference for various designs. Also, consumers were asked to evaluate labeling terminology and graphics to investigate how they interpret various ways of communicating drug safety and effectiveness. This document announces the availability of the frequency tabulations that summarize the Study B data, and reopens the comment period for the OTC rulemaking proceeding for 45 days to allow an opportunity to comment on these materials.

REQUEST FOR COMMENTS: Interested persons may, on or before (insert date 45 days after date of publication in the FEDERAL REGISTER) submit written comments on STUDY B to the Dockets Management Branch (HFA-305), ATTN: STUDY B: OTC Drug Labeling Data Collection, Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with docket number (insert from FR notice) and labeled "ATTN: STUDY B: OTC Drug Labeling Data Collection."



TABLE OF CONTENTS

Variable Frequencies

Demographic Information

  1. Interview Site
  2. Respondent Gender
  3. Respondent Age
  4. Need Glasses to Read
  5. Have Glasses
  6. Type of Questionnaire
  7. Marital Status
  8. Education
  9. Profession
  10. Health Rating
  11. How often have you purchased an over-the-counter cough/cold drug in the past six months?
  12. How often have you purchased an over-the-counter pain reliever drug in the past six months?
  13. How often have you purchased an over-the-counter sunscreen in the past six months?
  14. Are you being treated for any of these medical conditions?
  15. Annual Family Income
  16. Ethnicity

Terminology Ratings

  1. Completely Effective
  2. Moderately Effective
  3. Generally Effective
  4. Occasionally Effective
  5. Minimally Effective
  6. Frequently Effective
  7. Usually Effective
  8. Complete Relief
  9. Occasional Relief
  10. General Relief
  11. Moderate Relief
  12. Minimal Relief
  13. Frequent Relief
  14. Usual Relief

Graph Ratings 

Literacy Measure

FAT, FLU, PILL, DOSE, EYE, STRESS, SMEAR, NOTIFY, GALLBLADDER, CALORIES, DEPRESSION, MISCARRIAGE, PREGNANCY, ARTHRITIS, HEPATITIS, ANTIBIOTICS, INGREDIENT, TEMPORARY, EXCEED, INHALE, NAUSEA, EXCESSIVE, PHARMACIST, RELIEF, HEARTBURN, EFFECTIVENESS, DROWSINESS, PROLONGED, INHIBIT, PLACEBO, LIQUID, MUSCLE, DIAGNOSIS,POTASSIUM, ANEMIA, OBESITY, OSTEOPOROSIS, SYMPTOM, THALIDOMIDE, CONGESTION, CHRONIC, SINUSITIS 

Frequencies for Cough/Cold Questionnaire Items

  1. Label Ranked #1
  2. Label Ranked #2
  3. Label Ranked #3
  4. Label Ranked #4
  5. Label Ranked #5
  6. Label Ranked #6
  7. Label Ranked #7
  8. Label Ranked #8
  9. Label Ranked #9
  10. Label Ranked #10
  11. Label Ranked #11
  12. Label Ranked #12
  13. Label Ranked #13
  14. Label Ranked #14
  15. Label Ranked #15
  16. Label Ranked #16
  17. First label version rated
  18. How willing would someone be to read the label?
  19. How useful is the label in helping someone decide whether or not to use the drug?
  20. How much do you like the format or layout of the label?
  21. How easy is it to find information on the label?
  22. How believable is the information on the label?
  23. How difficult was it to read the label?
  24. How important would it be for someone to read all the information on the label?
  25. How confusing is the format or layout of the label?
  26. How well organized is the format or layout of the label?
  27. How much do you trust the information in the label?
  28. How confident would you be relying on the information in the label?
  29. How biased is the information in the label?
  30. Second label version rated
  31. How willing would someone be to read the label?
  32. How useful is the label in helping someone decide whether or not to use the drug?
  33. How much do you like the format or layout of the label?
  34. How easy is it to find information on the label?
  35. How believable is the information on the label?
  36. How difficult was it to read the label?
  37. How important would it be for someone to read all the information on the label?
  38. How confusing is the format or layout of the label?
  39. How well organized is the format or layout of the label?
  40. How much do you trust the information in the label?
  41. How confident would you be relying on the information in the label?
  42. How biased is the information in the label?

Frequencies for Sunscreen Questionnaire Items

  1. Label Ranked #1
  2. Label Ranked #2
  3. Label Ranked #3
  4. Label Ranked #4
  5. Label Ranked #5
  6. Label Ranked #6
  7. Label Ranked #7
  8. Label Ranked #8
  9. Label Ranked #9
  10. Label Ranked #10
  11. Label Ranked #11
  12. Label Ranked #12
  13. Label Ranked #13
  14. Label Ranked #14
  15. Label Ranked #15
  16. Label Ranked #16
  17. First label version rated
  18. How willing would someone be to read the label?
  19. How useful is the label in helping someone decide whether or not to use the drug?
  20. How much do you like the format or layout of the label?
  21. How easy is it to find information on the label?
  22. How believable is the information on the label?
  23. How difficult was it to read the label?
  24. How important would it be for someone to read all the information on the label?
  25. How confusing is the format or layout of the label?
  26. How well organized is the format or layout of the label?
  27. How much do you trust the information in the label?
  28. How confident would you be relying on the information in the label?
  29. How biased is the information in the label?
  30. Second label version rated
  31. How willing would someone be to read the label?
  32. How useful is the label in helping someone decide whether or not to use the drug?
  33. How much do you like the format or layout of the label?
  34. How easy is it to find information on the label?
  35. How believable is the information on the label?
  36. How difficult was it to read the label?
  37. How important would it be for someone to read all the information on the label?
  38. How confusing is the format or layout of the label?
  39. How well organized is the format or layout of the label?
  40. How much do you trust the information in the label?
  41. How confident would you be relying on the information in the label?
  42. How biased is the information in the label?

Appendix

Copy of Questionnaire 

Cough/Cold Label Versions 

Sunscreen Label Versions 

Graph Versions