Labeling OTC Human Drug Products Using a Column Format

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Guidance for Industry
Labeling OTC Human Drug Products
Using a Column Format
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
December 2000
OTC

Guidance for Industry
Labeling OTC Human Drug Products
Using a Column Format
Additional copies of this Guidance are available from:
Office of Training and Communications
Division of Communications Management
Drug Information Branch, HFD-210
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
(Phone 301-827-4573)
Internet: 	http://www.fda.gov/cder/guidance/index.htm.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
December 2000
OTC

TABLE OF CONTENTS
I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
II. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
III. USING COLUMNS AS PART OF THE STANDARD LABELING FORMAT . . . . . .2
A. VERTICAL BARLINE/HAIRLINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
B. NUMBER OF BOXES PER SIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
C. BOX OR COLUMN SIZE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
D. TITLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
E. VISUAL GRAPHICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
F. ORDER AND FLOW OF INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
G. ACTIVE INGREDIENTS/PURPOSE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . .4
IV. COLUMNS UNDER THE MODIFIED LABELING FORMAT . . . . . . . . . . . . . . . . . .4

Guidance for Industry1
Labeling OTC Human Drug Products
Using a Column Format
I. INTRODUCTION
This guidance is intended to assist manufacturers, packers, and distributors who wish to present
labeling information for their over-the-counter (OTC) human drug products using a column for-
mat.
II. BACKGROUND
In the Federal Register of March 17, 1999 (64 FR 13254), the Food and Drug Administration
(FDA) published a final regulation establishing standardized content and format requirements
for the labeling of OTC human drug products. Standardized labeling for OTC drug products is
intended to make it easier for consumers to read and understand OTC drug product labeling and
use OTC drug products safely and effectively.
The new Drug Facts labeling regulation in 21 CFR 201.66 covers all OTC drug and drug-cos-
metic products, whether marketed under a new drug marketing application (NDA), abbreviated
new drug application (ANDA), or OTC drug monograph (or product not yet the subject of a
final OTC drug monograph).
Section 201.66(d)(5) of the labeling regulation provides that the Drug Facts labeling informa-
tion may appear on more than one panel on the outside container of the retail package, or on the
immediate container label if there is no outside container or wrapper. When continuing the
required content and format information onto multiple panels, the required order and flow of
1
1 This guidance has been pr epared by the Division of Over-the-Counter (OTC) Drug Products in the Center for Drug Evaluation
and Research (CDER) at the Food and Drug Administration (FDA).
This guidance represents the Food and Drug Administration’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.
An alternative approach may be used if such approach satisfies the requirements of the applicable
statutes and regulations.

headings, subheadings, and information must be maintained as well. The regulation also
requires the use of a visual graphic (e.g., an arrow) to signal the continuation of the Drug Facts
labeling to the next adjacent panel.
The Agency received a number of inquiries as to whether the required labeling information may
be presented using a column format. One question is whether the required headings, subhead-
ings, and text can be divided into columns within a single, defined Drug Facts box or similar
enclosure (hereafter referred to together as the Drug Facts box), or whether such an approach
would be inconsistent with the final rule. The final format for the Drug Facts box generally
favors a vertical, linear presentation, to enhance readability and facilitate product comparisons.
Except for the presentation of active ingredient and purpose information (see § 201.66(d)(6))
and the use of a table to present complex dosing information (see § 201.66(d)(9)), the final for-
mat does not allow required information to be separated into columns within a given Drug Facts
box. However, the rule does allow for the use of an alternative column format that can help to
maximize available labeling space and, in some instances, improve readability. Specifically,
this guidance describes how more than one Drug Facts box can appear on each side of a pack-
age or a container to allow for the use of columns.
III. USING COLUMNS AS PART OF THE STANDARD LABELING FORMAT
The format established by the regulation requires most headings, subheadings, and text to be
left justified (see § 201.66(d) and (d)(4)). The regulation also requires the use of horizontal bar-
lines and hairlines — extending to each side of the Drug Facts box — to provide separation
between headings and subheadings (see § 201.66(d)(8)). These requirements contribute to the
overall organization of the information, provide the user with easy and consistent access to
required information, and help maximize the amount of open space within the Drug Facts box.
More open space (i.e., space not occupied by text) generally contributes to greater readability.
The regulation, however, can accommodate the use of more than one Drug Facts box on each
side of a package container (see Fig. 1), or the use of side-by-side Drug Facts boxes on a wrap-
around label (e.g., the label of a bottle of cough syrup). Such a presentation generally is consis-
tent with the rule, provided it is done in a manner that allows for the clear and legible presenta-
tion of all required labeling information. In the case of elongated packages (such as toothpaste
and topical ointment packages), the column format may noticeably improve readability.
The following recommendations should be helpful if you are considering the use of columns in
OTC drug product labeling.
A. Vertical Barline/Hairline
If you are using two or more Drug Facts boxes on the same side of a package, the right side of
the first column and the left side of the second column can share a common vertical barline
extending to each end of the Drug Facts box (see Fig. 1). This also applies to the right side of
the second column and the left side of the third column, if a third column is used.
2

B. Number of Boxes Per Side
• Different sides of a package do not have to contain the same number of Drug Facts boxes.
• Two or more Drug Facts boxes can appear on one or more sides of a package, and a single
Drug Facts box can appear on one or more sides of a package.
• If you are using two or more Drug Facts boxes on the same side of a package, the first
Drug Facts box or column should be to the left of each successive box (see Fig. 1).
C. Box or Column Size
When multiple Drug Fact boxes appear on the same side of a package, the boxes, enclosures, or
columns should be approximately the same size (see Figs. 1 and 2).
D. Titles2
• The first Drug Facts box must bear the title Drug Facts (see Figs. 1 and 2)
• Subsequent boxes on the same side of the package must bear the title Drug Facts
(continued) at the top of the box (see Figs. 1 and 2).
• If the Drug Facts information appears on more than one side of the package, each box on
each subsequent side of the package must bear the title Drug Facts (continued) (see Fig. 3).
E. Visual Graphics
If Drug Facts information appears in two or more columns on one side of a package (see Figs. 1
and 2) or on more than one side of a package (see Fig. 3), a visual graphic (e.g., an arrow)
should be used at the bottom of the first column and/or side of the package (and at the bottom
of subsequent columns and/or sides of the package, where needed) to signal continuation of the
Drug Facts labeling to the next appropriate Drug Facts box on the package.
F. Order and Flow of Information
The continuation of the required labeling onto multiple Drug Facts boxes or columns must be
done in a manner that retains the order and flow of headings, subheadings, and information,
meeting all the requirements of § 201.66.
3
2 These title formats are required in 21 CFR 201.66(c)(1) and (d)(5).

G. Active Ingredients/Purpose Information
• 	Section 201.66(d)(6) requires Active Ingredients information to be left justified and the
corresponding Purpose information to be right justified. The regulation requires that this
information be presented in a manner that readily associates each active ingredient with its
purpose.
• 	When multiple Drug Facts boxes are used, it is important that the boxes be wide enough to
allow the Active Ingredients and Purpose information to appear on the same horizontal
line.
• 	Where the Drug Facts box is too narrow to accommodate the Active Ingredient(s) (in each
dosage unit) and Purpose headings on the same line, the dosage unit information (in each
dosage unit) required under § 201.66(c)(2) may appear on the same line as the heading
Active Ingredient(s) or immediately under the heading Active Ingredient(s) on the next line
using left justification (see Fig. 3).
IV. 	COLUMNS UNDER THE MODIFIED LABELING FORMAT
When the Drug Facts labeling requires more than 60 percent of the total surface area available
to bear labeling, the regulation provides that the box required in § 201.66(d)(8) may be omitted
if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast
(§ 201.66(d)(10)(v)). In such a case, if more than one Drug Facts box or column is used on the
same side of a package, or side-by-side on a wrap-around label, the columns should be separat-
ed by adequate vertical common space of a contrasting color (see Fig. 2). Horizontal barlines
and hairlines should begin and end where the text begins and ends and should not extend into
the common space between the columns.
4

Figure 1. Drug Facts in Columns
Two Drug Facts Boxes on One Side of a Package
Standard Labeling Format
Package with Carton Riser
Drug Facts
Do not use n on broken skin
Do not use n on large areas of the body
When using this product
n apply to affected areas only
n avoid unnecessary sun exposure and use a
sunscreen
n do not use in or near the eyes
n this product may bleach hair or dyed fabrics
n using other topical acne drugs at the same time or
right after use of this product may increase dryness
or irritation of the skin. Only one drug should be
used unless directed by a doctor.
For external use only
Warnings
Uses n treats acneMMn dries up acne pimples
Uses n helps prevent new acne pimples
Active ingredient Purpose
Benzoyl peroxide 10%.................Acne treatment cream
Stop use and ask a doctor if too much skin irritation
or sensitivity develops or increases
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center
right away.
Directions
n clean the skin thoroughly before applying
n cover the entire affected area with a thin layer 1 to
3 times daily
n because too much drying of the skin may occur, start
with 1 application daily, then gradually increase to
2 to 3 times daily if needed or as directed by a doctor
n if bothersome dryness or peeling occurs, reduce
application to once a day or every other day
n if going outside, use a sunscreen. Allow benzoyl
peroxide to dry, then follow directions in the
sunscreen labeling.
Other information store at 20-25O C (68-77O F)
Inactive ingredients aluminum hydroxide gel,
bentonite, carbomer-940, dimethicone, glyceryl stearate
SE, isopropyl myristate, methylparaben, PEG-12,
potassium hydroxide, propylene glycol, propylparaben,
purified water
Drug Facts (continued)
* Note: 14 point Helvetica Bold Italic Title
8 point Helvetica Bold Italic Headings
6 point Helvetica Bold Subheadings
6 point Helvetica Regular Text
7 point Leading

Figure 2. Drug Facts in Columns
Two Drug Facts Boxes on One Side of a Package
Modified Labeling Format
Drug Facts
Active ingredient Purpose
(in each lozenge)
Hexylresorcinol 2.4 mg..Oral anesthetic
Use temporarily relieves occasional:
n minor irritationMM n pain
n sore mouthMM n sore throat
Warnings
Sore throat warning: Severe or
persistent sore throat or sore throat
that occurs with high fever, headache,
nausea, and vomiting may be serious.
Ask a doctor right away. Do not use
more than 2 days or give to children
under 3 years of age unless directed
by a doctor.
Drug Facts (continued)
Stop use and ask a doctor if n sore
throat is severe or irritation, pain or
redness lasts and worsens MM n sore
mouth does not impro ve in 7 days
Keep out of reach of children. In
case of overdose, get medical help or
contact a Poison Control Center right
away.
Directions n adults and children
3 years and older: dissolve 1 lozenge
slowly in the mouth. May be repeated
every 2 hours as needed or as
directed by a doctor.MMn children
under 3 years: ask a doctor
Inactive ingredients corn
syrup, D&C blue 1, D&C yellow 10,
mineral oil, silicon dioxide, sucrose
* Note: 9 point Helvetica Narrow Bold Italic Title
8 point Helvetica Narrow Bold Italic Headings
6 point Helvetica Narrow Bold Subheadings
6 point Helvetica Narrow Text
6 point Leading
Box barline omitted; color contrast used to highlight Drug Facts information

Figure 3. Drug Facts with Active
Ingredients Information on Two Lines
(For Single or Multiple Drug Facts Boxes)
Standard Labeling Format
Outer Carton
* Note: 14 point Helvetica Narrow Bold Italic Title
8 point Helvetica Narrow Bold Italic Headings
6 point Helvetica Narrow Bold Subheadings
6 point Helvetica Narrow Text
7 point Leading
Drug Facts
Do not use if you are now taking a prescription
monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychiatric or emotional conditions,
or Parkinson’s disease), or for 2 weeks after
stopping the MAOI drug. If you do not know if your
prescription drug contains an MAOI, ask a doctor
or pharmacist before taking this product.
Warnings
Uses
n temporarily relieves:
n cough due to minor throat and bronchial
irritation from inhaled irritants
n nasal congestion due to common cold
n helps loosen phlegm (mucus) and thin bronchial
secretions to make coughs more productive
Active ingredient Purpose
(in each 5 mL)
Dextromethorphan HBr 5 mg................Antitussive
Guaifenesin 100 mg.............................Expectorant
Pseudoephedrine HCl 15 mg....Nasal decongestant Directions
n do not take more than 4 doses in 24 hours
Drug Facts (continued)
Ask a doctor before use if you have
n heart diseaseMM n high blood pressure
n thyroid diseaseMMn diabetes
n trouble urinating due to an enlarged prostate gland
n cough that occurs with too much phlegm (mucus)
n chronic cough that lasts as occurs with smoking,
asthma, chronic bronchitis, or emphysema
When using this product
n do not use more than directed
Stop use and ask a doctor if
n you get nervous, dizzy, or sleepless
n symptoms do not get better within 7 days or
occur with a fever
n cough lasts more than 7 days, comes back, or
occurs with fever, rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center
right away.
adults and children
12 years and over
children 6 years to
under 12 years
children 2 years to
under 6 years
children under
2 years
take 20 mL every 4 hours
take 10 mL every 4 hours
take 5 mL every 4 hours
ask a doctor
Inactive ingredients caramel, citric acid,
D&C red no. 33, edetate disodium, FD&C red no. 40,
poloxamer 407, polyethylene glycol 1450,
propylgallate, propylene glycol, purified water,
saccharin sodium, sodium benzoate, sodium
chloride, sodium citrate, sorbitol solution