Professional Documents
Culture Documents
Table of Contents
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND ............................................................................................................... 2
III. GENERAL CONSIDERATIONS ................................................................................... 3
A. Poor Design of Product Container Labels and Carton Labeling Can Obscure
Critical Safety Information.............................................................................................. 3
B. Risk Assessment During the Design Stage Can Reduce the Risk of Medication
Errors................................................................................................................................. 4
C. Critical Product Information Should Appear on the Principal Display Panel ........... 4
D. Labels Should be Legible, Readable, and Easy to Understand .................................... 4
1. Container Label Size..................................................................................................... 5
2. Text Size and Style ........................................................................................................ 5
3. Contrast of Text and Background Color....................................................................... 6
4. Information Crowding and Visual Clutter.................................................................... 6
5. Dangerous Abbreviations, Acronyms, and Symbols..................................................... 7
E. Avoid Look-alike Container Labels and Carton Labeling ........................................... 7
1. Corporate Trade Dress................................................................................................. 7
2. Use of Color.................................................................................................................. 8
IV. SPECIAL CONSIDERATIONS AND RECOMMENDATIONS ................................ 9
A. Proprietary, Established, and Proper Names................................................................. 9
B. Product Strength............................................................................................................. 10
1. Strength Differentiation .............................................................................................. 10
2. Strength Designation .................................................................................................. 10
3. Small Volume Parenteral Products ............................................................................ 10
4. Expression of Strength for Dry Powder Products ...................................................... 11
5. Salt Nomenclature....................................................................................................... 11
6. Prodrugs ..................................................................................................................... 12
7. Metric Measurements.................................................................................................. 12
8. Location of Net Quantity Statements .......................................................................... 12
9. Leading and Terminal Zeros, Decimals, and Commas .............................................. 12
C. Route(s) of Administration............................................................................................. 13
D. Warnings for Critical Information................................................................................ 13
E. Expiration Dates.............................................................................................................. 13
F. Bar Codes......................................................................................................................... 13
G. National Drug Code Numbers ....................................................................................... 14
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