Drug-related Knowledge Base

The U.S. Food and Drug Administration (FDA) have specific requirements on content and format of labeling for human prescription drug and biological products.2 The labeling (also known as the “package insert”) contains scientific information needed for the safe and effective use of drugs. The labels are written for healthcare practitioners because prescription drug use requires professional supervision by a clinician licensed by law to administer such drugs.

The labeling is accurate and does not contain promotional or misleading information such as implied claims for drug use. It is updated when new information becomes available that causes the labeling to become inaccurate. Whenever possible, labeling is based on data derived from human experience. Manufacturers are required to submit to the FDA prescription drug labeling information under specific headings and subheadings, and in a specified order (Table 1).2

Table 1. Full content and format of labeling for human prescription drug and biological products.
Warning Box

  1. Indications and Usage
  2. Dosage and Administration
  3. Dosage Forms and Strengths
  4. Contraindications
  5. Warnings and Precautions
  6. Adverse Reactions
  7. Drug Interactions
  8. Use in Specific Populations
    1. Pregnancy
    2. Lactation
    3. Females and males of reproductive potential
    4. Pediatric use
    5. Geriatric use
  1. Drug Abuse and Dependence
    1. Controlled substance
    2. Abuse
    3. Dependence
  2. Overdose
  3. Description
  4. Clinical Pharmacology
    1. Mechanism of action
    2. Pharmacodynamics
    3. Pharmacokinetics
  5. Nonclinical Toxicology
    1. Carcinogenesis, mutagenesis, impairment of fertility
    2. Animal toxicology and/or pharmacology
  6. Clinical Studies
  7. References
  8. How Supplied/Storage and Handling
  9. Patient Counseling Information

DailyMed is the official source of FDA label information (package inserts).3 This website provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts. The drug labeling information on this website is the most recent submitted to the FDA, although these labels have been reformatted to make them easier to read and may include strengthened warnings undergoing FDA review.