Guidance for Industry
 
Dosage Delivery Devices for
 
Orally Ingested OTe Liquid
 
Drug Products
 
U.S. Department of Health and Human Services
 
Food and Drug Administration
 
Center for Drug Evaluation and Research (CDER)
 
May20n
 
Compliance
  Guidance for Industry
 
Dosage Delivery Devices for
 
Orally Ingested OTe Liquid
 
Drug Products
 
Additional copies are available from: 
Communications 
Offce of 

Drug Information, W051, Room 2210 
Division of 

Food and Drug Administration 
10903 New Hampshire Ave. 
Silver Spring, MD 20993-0002 
Phone: 301-796-3400; Fax: 301-847-8714
 
http://www.fda.gov/cder/guidance/inde.Y.htm 
Health and Human Services 
U.S. Department of 

Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
May 2011
 
Compliance
  TABLE OF CONTENTS
 
I. INTRODUCTION .............................................................................................................1
 
II. BACKGROUND ................................................................................................................2
 
III. REGULATORY/POLICY DISCUSSION.......................................................................2
 
A. Statutory Requirements and Regulatory History .......................................................................2
 
B. Recommendations ..........................................................................................................................3
 
APPENDIX A: EXAMPLES OF DOSAGE CUPS THAT DO NOT CORRSPOND TO 
DOSAGE DIRECTIONS ..............................................................................................................7
 
APPENDIX B: EXAMPLE OF DOSAGE CUP THAT CORRSPONDS TO DOSAGE
 
DIRECTIONS ..............................................................................................................................11
  Contains Nonbinding Recommendations 
Guidance for Industryl 
Dosage Delivery Devices for Orally Ingested OTe Liquid
 
Drug Products
 
This guidance represents the Food and Drug Administration's (FDA'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. 
the applicable statutes and 
You may use an alternative approach if  it satisfies the requirements of 

responsible for 
regulations. If  you want to discuss an alternative approach, contact the FDA staff 

implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance. 
I. INTRODUCTION
 
This document is intended to provide guidance to firms that are manufacturing, marketing, or 
distributing orally ingested over-the-counter (OTC) liquid drug products (e.g., elixirs, 
suspensions, solutions, syrups) that are packaged with dosage delivery devices (e.g., calibrated 
cups, droppers, syringes, spoons)? Because written, printed, or graphic matter appearing on 
dosage delivery devices packaged with aTC liquid drug products is considered labeling, such 
markings on these devices must not be false or misleading and must be clear and consistent with 
the Federal
the drug product's directions for use. (See sections 201  (m), 502(a) and 502()(1) of 

Food, Drug, and Cosmetic Act.) 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
the word should in Agency guidances means that something 
requirements are cited. The use of 

is suggested or recommended, but not required. 
i This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and Drug 
Administration.
2 This guidance is not intended to address the adequacy of dosage delivery devices to deliver the labeled dosage. It 
these liquid drug products packaged with 
is the responsibility of  the manufacturers, packers, and distributors of 

dosage delivery devices to ensure that the accompanying dosage delivery devices accurately deliver the doses 
identified by the measurements. FDA may issue additional guidance regarding the adequacy of dosage delivery 
devices to deliver the labeled dosage and to ensure that consumers can properly use dosage delivery devices that 
accompany aTC liquid drg products.  Contains Nonbinding Recommendations 
II. BACKGROUND
 
Many orally ingested aTC liquid drug products are packaged with dosage delivery devices 
intended to facilitate proper dispensing of the product by the patient, parent, or caregiver. In 
measure marked on the device (e.g., teaspoon,
most cases, these devices have calibrated units of 
tablespoon, or mililiter) that are intended to ensure proper measurement of  the appropriate dose.
 
However, many orally ingested aTC liquid drug products in the marketplace are packaged with 
dosage delivery devices that bear markings that are inconsistent with the labeled dosage 
directions. For example: 
. A provided dosage device may contain superfluous liquid measure markings that are not 
referred to in the product's labeled dosage directions. 
. A provided dosage device may be missing necessary liquid measure markings that are
 
referred to in the product's labeled dosage directions. 
. There may be inconsistencies in the language used (e.g., "teaspoon" versus "tsp") in a 
product's labeled dosage directions and the provided dosage device. 
There have been numerous reports of accidental overdose that were attributed, in part, to liquid 
measure markings on dosage cups provided with orally ingested aTC liquid drug products that 
were misleading or incompatible with the labeled dosage directions for use. In addition, these 
diffculties may lead consumers to use less accurate means (e.g., household spoons) to give 
children medication, leading to underdosing or overdosing. FDA is especially concerned 
because orally ingested aTC liquid drug products are frequently intended to be used in pediatric 
patients. 
FDA is issuing this guidance because of ongoing safety concerns about the serious potential for 
drug overdoses of orally ingested aTC liquid drug products that can result from the use of 
dosage delivery devices with markings that are inconsistent or incompatible with the labeled 
dosage directions for aTC drug products. 
III. REGULATORY/POLICY DISCUSSION
 
A. Statutory Requirements and Regulatory History
 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 352) states that 
Section 502 of 

a drug is considered to be misbranded: 
its labeling is false or misleading in any particular (or) . . .
(a) if 

adequate directions for use. . . .
(f) unless its labeling bears (1) 

the FD&C Act further defines labeling as "all labels and other written, 
Section 201(m) of 

printed, Or graphic matter (l) upon any article or any of its containers or wrappers, or (2) 
accompanying such article" (21 U.S.C 321(m)). The Agency considers any written, printed, or 
graphic matter, including measurements on dosage delivery devices, packaged with aTC liquid 
drug products to be labeling. FDA has issued notices and Warning Letters that cite misbranding 
the FD&C Act (21 U.S.C. 352(a)) when markings on dosage
violations under section 502(a) of 

2  Contains Nonbinding Recommendations 
delivery devices are inconsistent with the labeled dosage directions. Examples include the 
following: 
. On December 9, 1991, FDA issued a Compliance Notice to alert all drugestablishrents that 
were registered with the Agency to review the labeling of all drug products marketed with an 
the product's labeling was compatible 
accompanying dosage delivery device to determine if 

with the markings on the dosage device, and make corrections where necessary. 
In this notice, FDA said that dosage delivery devices that had markings inconsistent with the 
product's labeling rendered the drug product misbranded under 21 u.s.e. 352(a). 
. On January 21, 1992, FDA issued a Public Health Announcement warning parents against
 
the inadvertent overdosing of children with liquid OTe medications for colds and flu. 
. Between November 1991 and January 1992, FDA issued Warning Letters to five firms that 
were marketing OTe liquid drug products with dosage delivery devices that were not 
compatible with the products' labeled dosage directions. Those letters cited violations of 
the FD&e Act (21 u.s.e. 352(a)) because the markings on the dosage cups 
section 502(a) of 

packaged with the products were misleading within the context of the labeled directions for 
use. Eight firms initiated recalls of over 980,000 retail units nationwide of OTe oral liquid 
drug products that had misleading or incompatible dosage delivery devices during the same 
time period. Since January 1992, several other firms have conducted large-scale recalls of 
liquid drug products with misleading or incompatible dosage delivery devices.
OTe oral 

. On January 17,2008, FDA issued a Public Health Advisory recommending that when giving 
OTe cough and cold medicines to children ages 2 years and older, parents and caregivers use 
only the measuring spoons or cups that corne with the medicine or those made specially for 
measuring drugs. 
Despite these efforts, through routine monitoring and surveilance programs, FDA is aware that 
an increasing number of orally ingested OTe liquid drug products are packaged with dosage 
delivery devices that are incompatible with labeled product dosage directions. 
the FD&e Act (21 u.s.e. 352(a)), when 
In addition to misbranding under section 502(a) of 

dosage delivery devices packaged with OTe liquid drug products fail to bear a liquid measure 
mark or markings consistent with the labeled dosage directions, the products also lack adequate 
the FD&e Act (21 u.s.e.
directions for use and are misbranded under section 502(f)(1) of 

352(f)(1)). 
B. Recommendations
 
The Agency makes the following recommendations for orally ingested OTe liquid drug 
products: 
. Dosage delivery devices should be included for all orally ingested OTe drug products that 
are liquid formulations. 
3  Contains Nonbinding Recommendations 
. These devices should have calibrated units of liquid measure marked on the device (e.g., 
teaspoon, tablespoon, or mililiter) that are the same as the units of liquid measure specified 
in the labeled dosage directions on any outside packaging (carton labeling), bottle, and any 
accompanying written instructions. 
. If units of liquid measure are abbreviated on the dosage delivery device, the abbreviation
 
same abbreviation used in the labeled dosage directions, 
used on the device should be the 

outside packaging (carton labeling), bottle, and any accompanying written instructions. 
- International or national standards for abbreviations should be used. For example,
 
mililiters should be abbreviated as "mL" and teaspoons abbreviated as "tsp," and less 
common or nonstandard used abbreviations should be avoided. 
trailing zeros after decimal points ("4" not "4.0") to avoid IO-fold 
-Avoid the use of 

dosing errors. 
- Abbreviations should be defined on the dosage device (e.g., tsp = teaspoon) and, if 
they are not, should be defined in the labeled dosage directions, outside packaging 
(carton labeling), bottle, and any accompanying written instructions. 
. Any decimals or fractions included on dosage delivery devices should be listed as clearly as 
possible. 
- Use leading zeroes before decimal points ("0.4" not ".4") to help avoid IO-fold
 
dosing errors. 
- Use smaller font size for numerals in fractions ("W' not "1/2") to help avoid 
interpreting "1/2" as "lor 2."
 
. Dosage delivery devices should not bear extraneous or unnecessary liquid measure markings
 
that may be confusing. 
. Manufacturers should try to ensure that the dosage delivery devices are used only with the 
products with which they are included. Possible ways of accomplishing this are to either 
- Include a statement on the drug product's bottle andlor carton labeling and, if
 
possible, on the dosage delivery device that only the provided dosage delivery device 
is to be used with the particular aTe drug product with which it is included. This 
information can also be included under the Directions section of the product's Drug 
Facts paneL.
 
or 
- Devise a mechanism to secure the dosage delivery device to the drug product, such as 
creating an integrated dosage device. 
. Dosage delivery devices should not be significantly larger than the largest dose described in 
the labeled dosage directions and should permit clear measurement and delivery of the
smallest labeled dosage.3 . 
3 As an example, for concentrated acetaminophen infant drops, the Agency recommends that dosage delivery 
the smallest intended dosage consistent with
devices should also permit clear measurement and delivery of 

labeling for infants under 2 years of age. 
professional 
4  Contains Nonbinding Recommendations 
. The liquid measure markings on dosage delivery devices should be clearly visible and not be 
obscured when the liquid product is added to the device. 
The Agency also recommends that firms conduct usability studies to ensure that dosage delivery 
devices are easily understood and accurately used by consumers.4 
Because the Agency regards the markings on these delivery devices as labeling, FDA considers 
their failure to bear liquid measure markings consistent with the labeled dosage directions to 
the bottle and/or carton labeling for a 
cause the drug product to be misbranded. For example, if 

drug product contains dosage directions that are written exclusively in terms of a specific unit of 
measure, the accompanying dosage delivery device should contain liquid measure markings in 
the same unit of measure. The following examples ilustrate situations that would render the 
products misbranded: 
Example 1: The directions for use on the bottle and/or carton specify teaspoon measures 
to describe the dosage amount; the dosage cup that is supplied with the product bears 
three different graduated scales (one is a combined scale of 
teaspoonfuls/dessertspoonfuls/tablespoonfuls; the second provides metric measurements 
fluid ounces and drams) (see Appendix A,
(cc/ml); and, the third is a combined scale of 

Ilustration #2).
 
Example 2: The directions for use on the bottle and/or caron specify teaspoon measures 
to describe the dosage amount; the dosage cup provided with the product bears two 
different graduated scales (one is a combined scale of teaspoonfuls/tablespoonfuls with 
juxtaposed conversions to mililiters (Note: the ilustration also has a dessertspoon 
mililiters and fluid ounces) (see Appendix
marking); the second is a combined scale of 

A, Ilustration #3).
 
The Agency also recommends that the dosage delivery device for a drug product provide 
markings that can readily measure the dosage indicated by the directions on the bottle and/or 
carton labeling. Again, the following examples ilustrate situations that would render the 
products misbranded: 
Example 3: The directions for use on the drug product's bottle and/or carton specify a 2
teaspoonful dose (see Appendix A, Ilustration #1); the dosage cup does not bear a 
corresponding 2-teaspoonful graduation (See Appendix A, Ilustration #2). 
Example 4: The directions for use on the drug product's bottle and/or carton specify Yi
teaspoonful dose (see Appendix A, Ilustration #3); the dosage cup does not bear a 
corresponding Yi-teaspoonful graduation (see Appendix A, Ilustration #4). 
Appendix B provides an example of a dosage cup that corresponds to the dosage directions on 
the drug product's bottle and/or carton labeling. 
4 Although this guidance is not intended to address the adequacy of dosage delivery devices to deliver the labeled 
dosage, the Agency may consider issuing future guidance to industry that addresses topics such as age, weight, 
solubilty, viscosity, patient populations, and instrctions for cleaning, reuse, and storage. 
5  Contains Nonbinding Recommendations 
In addition to the scenarios described above, FDA is concerned about products that include a 
dosage delivery device and provide directions for use that state: 
physician
Under 2 or 6, etc.) years of age: consult a 

The Agency recommends that firms educate pharmacists and health care providers about the 
need for consumers to obtain appropriate measuring devices when a physician recommends a 
dose that does not correspond to the dosing directions on the product labeling. 
6  Contains Nonbinding Recommendations 
APPENDIX A: EXAMPLES OF DOSAGE CUPS THAT DO NOT CORRSPOND TO
 
DOSAGE DIRECTIONS
 
BOTTLE AND/OR CARTON LABELING
 
ILLUSTRATION # 1
 
DrUfl Facts (continued) 
Directions 
.  do not take more than 6 doses in any 24 hour period 
.  use only with enclosed measuring cup 
. 
dose as follows 
adults and children 12 years of age and  2 teaspoons every 4 hours 
older 
1 teaspoon every 4 hours 
children 6 to 12 years of age 
children 2 years to 6 years of age  1/2 teaspoon every 4 hours. 
children under 2 years of age  Do not use 
Other information 
. 
store at 20 - 25C (68 - nOp) 
. 
alcohol free 
Inactive ingredients: (established names of each inactive ingredient listed in 
alphabetic order) 
Questions? call weekdays 9 AM to 5 PM EST at 1-800-XX- XX 
7  Contal14S Nonbinding Rcommendations 
DOSAGE CUP 
ILLUS.TRATION # 2 
( 
-: 11BS.  -. AI
- 10SSP.
 
--.1. STSPP..
 
. 2
 
A 
SIDE 
OOSO-30M L 
26-25
20-20 
.115 -15
10-10 
5 - 5
 
SIDES 
SIDE.C 
8  'j-; 
. Contains Nonbinding Rcommendations 
CUp; 
DOSAGE 
ILLUSTRATION # 3 
SIDE A . 
SIDEB 
9  Contains Nonbinding Recommendations 
DOSAGE CUP
 
IllUSTRATION # 4
 
-2  TSP. 
-1 TSP.
 
A  SIDE B 
SIDE 
10  Contains Nonbinding Recommendations 
APPENDIX B: EXAMPLE OF DOSAGE CUP THAT CORRSPONDS TO DOSAGE 
DIRECTIONS 
The example below ilustrates a dosage cup that corresponds to the dosage directions described 
in the drug facts panel below. 
BOTTLE AND/OR CARTON LABELING
 
DrUfl Facts (continued) 
Directions 
.  do not take more than 6 doses in any 24 hour period 
.  use only with enclosed measuring cup. 
.  dose as follows 
adults and children 12 years of age and  2 teaspoons (tsp) every 4 hours 
older 
1 teaspoon (tsp) every 4 hours 
children 6 to 12 years of age 
children 2 years to 6 years of age  'l teaspoon (tsp) every 4 hours. 
children under 2 years of age  Do not use 
Other information 
. 
store at 20 - 25C (68 - 77P) 
. 
alcohol free 
Inactive ingredients: (established names of each inactive ingredient listed in 
alphabetic order)
 
Questions? call weekdays 9 AM to 5 PM EST at 1-800-XX- XX 
-2 tsp
 
-1 tsp
 
- 'h tsp
 
11