Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA
21:4.0.1.1.2.7.1.26.1 : Appendix A
Appendix A to Part 201 - Examples of Graphic Enhancements Used by
FDA I. Section 201.66 Standard Labeling Format A. Overall
1. The “Drug Facts” labeling is set off in a box or similar
enclosure by the use of a barline with all black type printed on a
white, color contrasting background.
B. Typeface and size
1. “Drug Facts” is set in 14 point Helvetica Bold Italic, left
justified.
2. “Drug Facts (continued)” is set in 8 point Helvetica Bold
Italic for the words “Drug Facts” and 8 point Helvetica Regular for
the word “(continued)” and is left justified.
3. The headings (e.g., “Directions”) are set in 8 point
Helvetica Bold Italic, left justified.
4. The subheadings (e.g., “Ask a doctor or pharmacist before use
if you are”) are set in 6 point Helvetica Bold, left justified.
5. The information is set in 6 point Helvetica Regular with 6.5
point leading, left justified.
6. The heading “Purpose” is right justified.
7. The bullet is a 5-point solid square.
8. Two em spacing separates bullets when more than one bullet is
on the same line.
9. A table format is used for 3 or more dosage directions.
10. A graphic appears at the bottom of the first panel leading
the reader to the next panel.
C. Barlines and hairlines
1. A 2.5-point horizontal barline extends to each end of the
“Drug Facts” box (or similar enclosure), providing separation
between each of the headings.
2. A 0.5-point horizontal hairline extends within 2 spaces on
either side of the “Drug Facts” box (or similar enclosure),
immediately following the title and immediately preceding the
subheadings.
3. A 0.5-point horizontal hairline follows the title,
immediately preceding the heading, when a heading appears on a
subsequent panel immediately after the “Drug Facts (continued)”
title.
D. Box or Enclosure
1. All information is enclosed by a 2.5-point barline.
II. Section 201.66 Modified Labeling Format A. Overall
1. The “Drug Facts” labeling is presented in all black type
printed on a white color contrasting background.
B. Typeface and size
1. “Drug Facts” is set in 9 point Helvetica Bold Italic, left
justified.
2. The headings (e.g., “Directions”) are set in 8 point
Helvetica Bold Italic, left justified.
3. The subheadings (e.g., “Ask a doctor or pharmacist before use
if you are”) are set in 6 point Helvetica Bold, left justified.
4. The information is set in 6 point Helvetica Regular with 6.5
point leading, left justified.
5. The heading “Purpose” is right justified.
6. The bullet is a 5-point solid square.
7. Bulleted information may start on same line as headings
(except for the “Warnings” heading) and subheadings, with 2 em
spacing separating bullets, and need not be vertically aligned.
C. Barlines and hairlines
1. A 2.5-point horizontal barline extends to each end of the
“Drug Facts” box (or similar enclosure), providing separation
between each of the headings.
2. A 0.5-point horizontal hairline extends within 2 spaces on
either side of the “Drug Facts” box (or similar enclosure),
immediately following the title and immediately preceding the
subheadings.
D. Box or Enclosure
1. All information is set off by color contrast. No barline is
used.
III. Examples of § 201.66 Standard Labeling and Modified Labeling
Formats A. Section 201.66 Standard Labeling Format
B. Section 201.66
Modified Labeling Format
