Prescribing Information (Package Insert) Explained
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Prescribing information

Also called package insert, PI, drug label, full prescribing information · Reviewed

Definition: Prescribing information is the FDA-approved label for a prescription drug, written mainly for health care providers. It is often called the package insert. It sets out what the drug is approved for, how it is dosed, its warnings, the side effects seen in trials and how it should be stored.

How it is laid out

Federal rules (21 CFR 201.57) set the order. Newer labels open with Highlights, a one-page summary that must say it does not include all the information needed to use the drug safely. Then come the numbered sections of the full label. The ones people look up most:

  • Boxed warning, if the drug has one. See boxed warning.
  • 1 Indications and usage: the conditions the drug is approved to treat.
  • 2 Dosage and administration and 3 Dosage forms and strengths.
  • 4 Contraindications and 5 Warnings and precautions.
  • 6 Adverse reactions: trial side-effect tables, usually against placebo.
  • 16 How supplied/storage and handling, and 17 Patient counseling information.

Where to find it

DailyMed, run by the National Library of Medicine, posts the current label for each product. Each label has a fixed ID called a setid, which is how Dose Track cites labels. Labels change over time, so the date of the version matters. Generic versions carry their own labels, which FDA says are the same as the brand label with certain exceptions.

Why it matters for your log

When a page on this site gives a number such as a side-effect rate or a storage limit, it names the product and label section it came from. Those numbers belong to that product and its approved use. They do not carry over to compounded or research products. For the shorter, patient-facing documents that may come with a drug, see medication guide.

Read more on Dose Track: Side effects from FDA labels · Fosamax side effects · Side-by-side comparisons

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
Boxed warningA boxed warning is a warning printed inside a border at the top of a US prescription drug label. FDA uses… Medication guideA Medication Guide is FDA-approved patient labeling that must be handed to the patient with certain… Off-label useOff-label use is using an FDA-approved drug in a way its label does not cover: for a different condition,… Generic drugA generic drug is an FDA-approved copy of a brand-name drug. FDA requires it to have the same active… Research use only (RUO)Research use only (RUO) is a label phrase. In US rules it comes from labeling for in vitro diagnostic…

Frequently asked questions

Is the package insert the same as prescribing information?+
Yes, in everyday use. Package insert is the common name for the printed prescribing information that comes with a drug.
Which section lists side effects?+
Section 6, Adverse reactions, holds the trial tables. Serious risks are in section 5, Warnings and precautions, and in the boxed warning if there is one.
Where can I read the current label?+
DailyMed, from the National Library of Medicine, posts current labels. Each Dose Track label page links to the version it used.

Sources

  1. 21 CFR 201.57: content and format of prescription drug labeling, Cornell LII
  2. Fosamax (alendronate) US prescribing information, DailyMed
  3. FDA: Generic drug facts

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