[Title 21 CFR C]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter C - DRUGS: GENERAL]
[Part 201 - LABELING]
[Subpart C - Labeling Requirements for Over-the-Counter Drugs]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  4
  1996-04-01
  1996-04-01
  false
  
  C
  Subpart C
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION,
    DRUGS: GENERAL
    LABELING
  


       Subpart C--Labeling Requirements for Over-the-Counter Drugs

    Source: 41 FR 6908, Feb. 13, 1976, unless otherwise noted.



Sec. 201.60   Principal display panel.

    The term principal display panel, as it applies to over-the-counter 
drugs in package form and as used in this part, means the part of a 
label that is most likely to be displayed, presented, shown, or examined 
under customary conditions of display for retail sale. The principal 
display panel shall be large enough to accommodate all the mandatory 
label information required to be placed thereon by this part with 
clarity and conspicuousness and without obscuring designs, vignettes, or 
crowding. Where packages bear alternate principal display panels, 
information required to be placed on the principal display panel shall 
be duplicated on each principal display panel. For the purpose of 
obtaining uniform type size in declaring the quantity of contents for 
all packages of substantially the same size, the term area of the 
principal display panel means the area of the side or surface that bears 
the principal display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;

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    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference; and
    (c) In the case of any other shape of container, 40 percent of the 
total surface of the container: Provided, however, That where such 
container presents an obvious ``principal display panel'' such as the 
top of a triangular or circular package, the area shall consist of the 
entire top surface.

In determining the area of the principal display panel, exclude tops, 
bottoms, flanges at the tops and bottoms of cans, and shoulders and 
necks of bottles or jars. In the case of cylindrical or nearly 
cylindrical containers, information required by this part to appear on 
the principal display panel shall appear within that 40 percent of the 
circumference which is most likely to be displayed, presented, shown, or 
examined under customary conditions of display for retail sale.



Sec. 201.61   Statement of identity.

    (a) The principal display panel of an over-the-counter drug in 
package form shall bear as one of its principal features a statement of 
the identity of the commodity.
    (b) Such statement of identity shall be in terms of the established 
name of the drug, if any there be, followed by an accurate statement of 
the general pharmacological category(ies) of the drug or the principal 
intended action(s) of the drug. In the case of an over-the-counter drug 
that is a mixture and that has no established name, this requirement 
shall be deemed to be satisfied by a prominent and conspicuous statement 
of the general pharmacological action(s) of the mixture or of its 
principal intended action(s) in terms that are meaningful to the layman. 
Such statements shall be placed in direct conjunction with the most 
prominent display of the proprietary name or designation and shall 
employ terms descriptive of general pharmacological category(ies) or 
principal intended action(s); for example, ``antacid,'' ``analgesic,'' 
``decongestant,'' ``antihistaminic,'' etc. The indications for use shall 
be included in the directions for use of the drug, as required by 
section 502(f)(1) of the act and by the regulations in this part.
    (c) The statement of identity shall be presented in bold face type 
on the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.



Sec. 201.62   Declaration of net quantity of contents.

    (a) The label of an over-the-counter drug in package form shall bear 
a declaration of the net quantity of contents. This shall be expressed 
in the terms of weight, measure, numerical count, or a combination or 
numerical count and weight, measure, or size. The statement of quantity 
of drugs in tablet, capsule, ampule, or other unit form and the quantity 
of devices shall be expressed in terms of numerical count; the statement 
of quantity for drugs in other dosage forms shall be in terms of weight 
if the drug is solid, semisolid, or viscous, or in terms of fluid 
measure if the drug is liquid. The drug quantity statement shall be 
augmented when necessary to give accurate information as to the strength 
of such drug in the package; for example, to differentiate between 
several strengths of the same drug ``100 tablets, 5 grains each'' or 
``100 capsules, 125 milligrams each'' or ``100 capsules, 250 milligrams 
each'': Provided, That:
    (1) In the case of a firmly established, general consumer usage and 
trade custom of declaring the quantity of a drug in terms of linear 
measure or measure of area, such respective term may be used. Such term 
shall be augmented when necessary for accuracy of information by a 
statement of the weight, measure, or size of the individual units or of 
the entire drug; for example, the net quantity of adhesive tape in 
package form shall be expressed in terms of linear measure augmented by 
a statement of its width.
    (2) Whenever the Commissioner determines for a specific packaged 
drug that an existing practice of declaring net quantity of contents by 
weight, measure, numerical count, or a combination of these does not 
facilitate value comparisons by consumers, he

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shall by regulation designate the appropriate term or terms to be used 
for such article.
    (b) Statements of weight of the contents shall be expressed in terms 
of avoirdupois pound and ounce. A statement of liquid measure of the 
contents shall be expressed in terms of the U.S. gallon of 231 cubic 
inches and quart, pint, and fluid-ounce subdivisions thereof, and shall 
express the volume at 68 deg. F (20 deg. C). See also paragraph (p) of 
this section.
    (c) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eights, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established, general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (d) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it shall be duplicated on each principal display panel.
    (e) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated, by at least a space equal to the 
height of the lettering used in the declaration, from other printed 
label information appearing above or below the declaration and, by at 
least a space equal to twice the width of the letter ``N'' of the style 
of type used in the quantity of contents statement, from other printed 
label information appearing to the left or right of the declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count, such as ``giant pint'' and ``full quart'', that tends to 
exaggerate the amount of the drug in the container. It shall be placed 
on the principal display panel within the bottom 30 percent of the area 
of the label panel in lines generally parallel to the base on which the 
package rests as it is designed to be displayed: Provided, That:
    (1) On packages having a principal display panel of 5 square inches 
or less the requirement for placement within the bottom 30 percent of 
the area of the label panel shall not apply when the declaration of net 
quantity of contents meets the other requirements of this part; and
    (2) In the case of a drug that is marketed with both outer and inner 
retail containers bearing the mandatory label information required by 
this part and the inner container is not intended to be sold separately, 
the net quantity of contents placement requirement of this section 
applicable to such inner container is waived.
    (3) The principal display panel of a drug marketed on a display card 
to which the immediate container is affixed may be considered to be the 
display panel of the card, and the type size of the net quantity of 
contents statement is governed by the dimensions of the display card.
    (f) The declaration shall accurately reveal the quantity of drug or 
device in the package exclusive of wrappers and other material packed 
therewith: Provided, That in the case of drugs packed in containers 
designed to deliver the drug under pressure, the declaration shall state 
the net quantity of the contents that will be expelled when the 
instructions for use as shown on the container are followed. The 
propellant is included in the net quantity declaration.
    (g) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of net quantity blown, embossed, or molded on a glass 
or plastic surface is permissible when all label information is so 
formed on the surface. Requirements of conspicuousness and legibility 
shall include the specifications that:
    (1) The ratio of height to width of the letter shall not exceed a 
differential of 3 units to 1 unit, i.e., no more than 3 times as high as 
it is wide.
    (2) Letter heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are

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used, it is the lower case letter ``o'' or its equivalent that shall 
meet the minimum standards.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (h) The declaration shall be in letters and numerals in a type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (1) Not less than one-sixteenth inch in height on packages the 
principal display panel of which has an area of 5 square inches or less.
    (2) Not less than one-eighth inch in height on packages the 
principal display panel of which has an area of more than five but not 
more than 25 square inches.
    (3) Not less than three-sixteenths inch in height on packages the 
principal display panel of which has an area of more than 25 but not 
more than 100 square inches.
    (4) Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than one-half inch in height if the area is more 
than 400 square inches.

Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (h) (1) through (4) of this 
section shall be increased by one-sixteenth of an inch.
    (i) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(k) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints, or pints, as 
appropriate) with any remainder in terms of fluid ounces or common or 
decimal fractions of the pint or quart (see examples set forth in 
paragraphs (k) (3) and (4) of this section). If the net weight of the 
package is less than 1 ounce avoirdupois or the net fluid measure is 
less than 1 fluid ounce, the declaration shall be in terms of common or 
decimal fractions of the respective ounce and not in terms of drams.
    (2) The declaration may appear in more than one line. The term net 
weight shall be used when stating the net quantity of contents in terms 
of weight. Use of the terms net or net contents in terms of fluid 
measure or numerical count is optional. It is sufficient to distinguish 
avoirdupois ounce from fluid ounce through association of terms; for 
example, ``Net wt. 6 oz'' or ``6 oz net wt.,'' and ``6 fl oz'' or ``net 
contents 6 fl oz''.
    (j) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fractions of the pound; in the case of fluid measure, 
it shall be expressed in the largest whole unit (gallons, followed by 
common or decimal fractions of a gallon or by the next smaller whole 
unit or units (quarts or quarts and pints)) with any remainder in terms 
of fluid ounces or common or decimal fractions of the pint or quart; see 
paragraph (k) (5) of this section.
    (k) Examples:
    (1) A declaration of 1\1/2\ pounds weight shall be expressed as 
``Net wt. 24 oz (1 lb 8 oz),'' or ``Net wt. 24 oz (1\1/2\ lb)'' or ``Net 
wt. 24 oz (1.5 lb)''.
    (2) A declaration of three-fourths pound avoirdupois weight shall be 
expressed as ``Net wt. 12 oz''.
    (3) A declaration of 1 quart liquid measure shall be expressed as 
``Net contents 32 fl oz (1 qt)'' or ``32 fl oz (1 qt)''.
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as ``Net contents 56 fl oz (1 qt 1 pt 8 oz)'' or ``Net contents 56 fl oz 
(1 qt 1.5 pt),'' but not in terms of quart and ounce such as ``Net 56 fl 
oz (1 qt 24 oz).''
    (5) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as ``Net contents 2 gal 2 qt,'' ``Net contents 2.5

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gallons,'' or ``Net contents 2\1/2\ gal'' but not as ``2 gal 4 pt''.
    (l) For quantities, the following abbreviations and none other may 
be employed. Periods and plural forms are optional:

Gallon gal                           milliliter ml                      
quart qt                             cubic centimeter cc                
pint pt                              yard yd                            
ounce oz                             feet or foot ft                    
pound lb                             inch in                            
grain gr                             meter m                            
kilogram kg                          centimeter cm                      
gram g                               millimeter mm                      
milligram mg                         fluid fl                           
microgram mcg                        square sq                          
liter l                              weight wt                          
                                                                        

    (m) On packages labeled in terms of linear measure, the declaration 
shall be expressed both in terms of inches and, if applicable (1 foot or 
more), the largest whole units (yards, yards and feet, feet). The 
declaration in terms of the largest whole units shall be in parentheses 
following the declaration in terms of inches and any remainder shall be 
in terms of inches or common or decimal fractions of the foot or yard; 
if applicable, as in the case of adhesive tape, the initial declaration 
in linear inches shall be preceded by a statement of the width. Examples 
of linear measure are ``86 inches (2 yd 1 ft 2 in),'' ``90 inches (2\1/
2\ yd),'' ``30 inches (2.5 ft),'' `` \3/4\ inch by 36 in (1 yd),'' etc.
    (n) On packages labeled in terms of area measure, the declaration 
shall be expressed both in terms of square inches and, if applicable (1 
square foot or more), the largest whole square unit (square yards, 
square yards and square feet, square feet). The declaration in terms of 
the largest whole units shall be in parentheses following the 
declaration in terms of square inches and any remainder shall be in 
terms of square inches or common or decimal fractions of the square foot 
or square yard; for example, ``158 sq inches (1 sq ft 14 sq in).''
    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents, provided that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the drug contained in the package; for example, 
``giant pint'' and ``full quart.'' Dual or combination declarations of 
net quantity of contents as provided for in paragraphs (a) and (i) of 
this section are not regarded as supplemental net quantity statements 
and shall be located on the principal display panel.
    (p) A separate statement of net quantity of contents in terms of the 
metric system of weight or measure is not regarded as a supplemental 
statement and an accurate statement of the net quantity of contents in 
terms of the metric system of weight or measure may also appear on the 
principal display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents of the package. 
Reasonable variations caused by loss or gain of moisture during the 
course of good distribution practice or by unavoidable deviations in 
good manufacturing practice will be recognized. Variations from stated 
quantity of contents shall not be unreasonably large.
    (r) A drug shall be exempt from compliance with the net quantity 
declaration required by this section if it is an ointment labeled 
``sample,'' ``physician's sample,'' or a substantially similar statement 
and the contents of the package do not exceed 8 grams.



Sec. 201.63  Pregnancy-nursing warning.

    (a) The labeling for all over-the-counter (OTC) drugs that are 
intended for systemic absorption, unless specifically exempted, shall 
contain a general warning under the heading Warning (or Warnings if it 
appears with additional warning statements) as follows: ``As with any 
drug, if you are pregnant or nursing a baby, seek the advice of a health 
professional before using this product.'' In addition to the written 
warning, a symbol that conveys the intent of the warning may be used in 
labeling.
    (b) Where a specific warning relating to use during pregnancy or 
while nursing has been established for a particular drug product in a 
new drug application (NDA) or for a product covered by an OTC drug final 
monograph in part 330 of this chapter, the specific warning shall be 
used in place of the warning in

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paragraph (a) of this section, unless otherwise stated in the NDA or in 
the final OTC drug monograph.
    (c) The following OTC drugs are exempt from the provisions of 
paragraph (a) of this section:
    (1) Drugs that are intended to benefit the fetus or nursing infant 
during the period of pregnancy or nursing.
    (2) Drugs that are labeled exclusively for pediatric use.
    (d) The Food and Drug Administration will grant an exemption from 
paragraph (a) of this section where appropriate upon petition under the 
provisions of Sec. 10.30 of this chapter. Decisions with respect to 
requests for exemptions shall be maintained in a permanent file for 
public review by the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (e) The labeling of orally or rectally administered OTC aspirin and 
aspirin-containing drug products must bear a warning that immediately 
follows the general warning identified in paragraph (a) of this section. 
The warning shall be as follows:

    ``IT IS ESPECIALLY IMPORTANT NOT TO USE'' (select ``ASPIRIN'' or 
``CARBASPIRIN CALCIUM,'' as appropriate) ``DURING THE LAST 3 MONTHS OF 
PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT 
MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING 
DELIVERY.''

[47 FR 54757, Dec. 3, 1982, as amended at 55 FR 27784, July 5, 1990; 59 
FR 14364, Mar. 28, 1994]