Guidelines for Medication Container Labels - USP Ch. 17

  • Emphasize instructions and other information important to patients. Prominently display information that is critical for patients’ safe and effective use of the medicine. At the top of the label specify patient name, drug name (spell out full nonproprietary and brand name) and strength, and clear directions for use in simple language. Less critical information (e.g., pharmacy name, drug quantity) should not supersede critical information and should be placed away from dosing instructions.
  • Improve readability.
    Labels should be designed and formatted so they are easy to read. Typography should be optimized by using high contrast print; adequate white space between lines of text (i.e., 25-30 percent of the point size); simple uncondensed familiar fonts (Times Roman or Arial are specifically recommended); and large font size (e.g., minimum 12-point Times Roman or 11-point Arial) for critical information. Older adults, in particular, have difficulty reading small print.
  • Give explicit instructions.
    Instructions for use should clearly separate the dose itself from the timing of each dose. Do not use alphabetic characters for numbers. For example, write, “Take 2 tablets in the morning and 2 tablets in the evening” rather than “Take 2 tablets twice daily.”
    Dosing intervals such as “twice daily,” “3 times daily,” or hourly intervals such as “every 12 hours” should be avoided because such instructions are implicit rather than explicit, may involve numeracy skills, and patient interpretation may vary from prescriber intent. Although instructions worded in terms of specific hourly times (e.g., 8 a.m. and 10 p.m.) may be assumed to be more easily understood, in actual use they are less readily understood and may present greater adherence issues due to individual lifestyle patterns (e.g., shift work) than general timeframes such as “in the morning” or “after breakfast.” Ambiguous directions such as “take as directed” should be avoided without clear supplemental information. When oral liquid dosage forms are prescribed, the appropriate dosing component (e.g., oral syringe, dosing cup) shall be provided to the patient or caregiver to accurately measure and administer the oral medication. The graduations on the component shall be legible and indelible, and the associated volume markings shall be in metric units and limited to a single measurement scale that corresponds with the dose instructions on the prescription container label.
  • Include purpose for use.
    If the purpose of the medication is included on the prescription, it should be included on the label unless a patient prefers that it not appear.
    Confidentiality and FDA approval for intended use (i.e., labeled vs. off-label use) may cause some to constrain its inclusion on labels. Current evidence supports inclusion of purpose-for-use language in clear, simple terms, e.g., “for high blood pressure” rather than “for hypertension.”
  • Address limited English proficiency.
    Whenever possible, the directions for use on a prescription container label should be provided in the patient’s preferred language. The drug name shall be in English as well so that emergency personnel can have quick access to the information. Translations should be produced using a high-quality translation process; an example is provided in the standard.
  • Address visual impairment.
    Provide alternative access for visually impaired patients (e.g., tactile, auditory, or enhanced visual systems that may employ advanced mechanics or assistive technology).