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
This guidance represents the Food and Drug Administrations 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.
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 
1This guidance has been prepared 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). 
1 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 withina 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.
2These title formats are required in 21 CFR 201.66(c)(1) and (d)(5). 
3 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 Ingredientsand 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 Drug Facts (continued)
Directions
Active ingredient                    Purpose
nclean the skin thoroughly before applying
Benzoyl peroxide 10%.................Acne treatment cream ncover the entire affected area with a thin layer 1 to
3 times daily  
Uses  ntreats acneMMndries up acne pimples nbecause too much drying of the skin may occur, start
Uses  nhelps prevent new acne pimples with 1 application daily, then gradually increase to
2 to 3 times daily if needed or as directed by a doctor  
Warnings nif bothersome dryness or peeling occurs, reduce
application to once a day or every other day
For external use only nif going outside, use a sunscreen.  Allow benzoyl
Do not use  non broken skin peroxide to dry, then follow directions in the
Do not use  non large areas of the body sunscreen labeling.
When using this product
nnaavpopildy  tuon anfefecectsesda rayr esausn  oenxlpyosure and use a Other information store at 20-25OC (68-77OF)
sunscreen 
ndo not use in or near the eyes Inactive ingredients aluminum hydroxide gel,
nthis product may bleach hair or dyed fabrics bentonite, carbomer-940, dimethicone, glyceryl stearate
nusing other topical acne drugs at the same time or SE, isopropyl myristate, methylparaben, PEG-12,
right after use of this product may increase dryness potassium hydroxide, propylene glycol, propylparaben,
or irritation of the skin.  Only one drug should be purified water
used unless directed by a doctor.
Stop use and ask a doctor iftoo 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.
* 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 Drug Facts (continued)
Active ingredient   Purpose Stop use and ask a doctor if nsore
(in each lozenge) rtherdonaets iss  lsaesvtse raen odr  wirorirtasetionns,M pMainn orsore
Hexylresorcinol 2.4 mg..Oral anesthetic mouth does not improve in 7 days
Usetemporarily relieves occasional: cKaeseep o of uotv eorfd roesaec,h g eotf  mcheidldicraeln h.elIpn or
nminor irritationMMnpain contact a Poison Control Center right
nsore mouthMM nsore throat away.
Warnings Directionsnadults and children
Sore throat warning:Severe or 3 years and older:dissolve 1 lozenge
persistent sore throat or sore throat slowly in the mouth. May be repeated
that occurs with high fever, headache, every 2 hours as needed or as
nausea, and vomiting may be serious. directed by a doctor.MMnchildren
Ask a doctor right away.Do not use under 3 years: ask a doctor
more than 2 days or give to children
under 3 years of age unless directed Inactive ingredientscorn
by a doctor. 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
Drug Facts Drug Facts(continued)
If pregnant or breast-feeding,ask a health
Active ingredient                 Purpose professional before use.
(in each 5 mL) Keep out of reach of children. In case of overdose,
Dextromethorphan HBr 5 mg................Antitussive get medical help or contact a Poison Control Center
right away.
Guaifenesin 100 mg.............................Expectorant
Pseudoephedrine HCl 15 mg....Nasal decongestant
Directions
ndo not take more than 4 doses in 24 hours
Uses
nntemcopuograhr dilyu er etloie mveisn:or throat and bronchial a1d2u yltesa rasn dan cdh ioldvreern take 20 mL every 4 hours
irritation from inhaled irritants
nnasal congestion due to common cold children 6 years to take 10 mL every 4 hours
nhelps loosen phlegm (mucus) and thin bronchial under 12 years
secretions to make coughs more productive children 2 years to
take 5 mL every 4 hours
under 6 years
Warnings
children under
Do not use ifyou are now taking a prescription ask a doctor
2 years
monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychiatric or emotional conditions,
or Parkinsons disease), or for 2 weeks after Inactive ingredients caramel, citric acid,
stopping the MAOI drug.  If you do not know if your D&C red no. 33, edetate disodium, FD&C red no. 40,
prescription drug contains an MAOI, ask a doctor poloxamer 407, polyethylene glycol 1450,
or pharmacist before taking this product. propylgallate, propylene glycol, purified water,
saccharin sodium, sodium benzoate, sodium
Ask a doctor before use if you have chloride, sodium citrate, sorbitol solution
nheart diseaseMM nhigh blood pressure
nthyroid diseaseMMndiabetes
ntrouble urinating due to an enlarged prostate gland
ncough that occurs with too much phlegm (mucus)
nchronic cough that lasts as occurs with smoking,
asthma, chronic bronchitis, or emphysema
When using this product
ndo not use more than directed
Stop use and ask a doctor if
nyou get nervous, dizzy, or sleepless
nsymptoms do not get better within 7 days or
occur with a fever
ncough lasts more than 7 days, comes back, or
occurs with fever, rash or headache that lasts.  
These could be signs of a serious condition.
* 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