Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling

Every prescription drug (including biological drug products) approved by
FDA for human use comes with FDA-approved labeling. The labeling
contains information necessary to inform healthcare providers about the
safe and effective use of the drug for its approved use(s). Once a
prescription drug is approved, the labeling may be updated as new
information becomes available, including, for example, new approved
uses, new dosing recommendations, and new safety information. Thus, the
approved labeling is a "living document" that changes over time to
reflect increased knowledge about the safety and effectiveness of the
drug.



Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling