AMA Package Insert Citation for Drug Labels and Prescribing Information

Identify the exact product label

Start with the file you actually read. Write down the brand and generic name, then identify the dosage form. A search for a drug can return prescribing information alongside patient material or packaging records. Choose the document that supports the passage in your paper before arranging its punctuation.

The current manufacturer PDF for Eliquis names apixaban and covers tablets, tablets for oral suspension, and Eliquis Sprinkle for oral suspension. It also contains patient-facing documents. In your notes, identify which part you used. A reference to the full prescribing information should use that document’s revision details.

Keep strength and product codes in your research notes when they help distinguish candidates. Use those details to choose the record. Include additional product identifiers in the finished reference when your assignment or the distinction between labels requires them. Reopen the chosen URL after drafting the reference and compare the product name again.

Separate the company from the database host

DailyMed is provided by the National Library of Medicine. Its About page describes labeling submitted to FDA by companies and distinguishes prescribing information from patient labeling. DailyMed supplies a route to the document. Its name does not establish which company belongs in the manufacturer position of your reference.

Look for responsibility statements inside the label. The selected DailyMed record names E.R. Squibb & Sons, L.L.C. as packager. Its prescribing text names Bristol-Myers Squibb Company and Pfizer Inc under “Marketed by.” Preserve those roles in your notes. A packager listing alone does not prove the physical manufacturer’s identity.

The worked references below retain both marketed-by companies as the responsible company names. They make no claim about the factory that made the product. If your label identifies a separate manufacturer, use the stated information and follow your instructor or journal’s requirements for that company field.

Find the revision date and stable record

MD Anderson’s library guidance ties the publication year to the package insert’s latest revision. For the particular document you cite, locate its own revision statement. A study’s publication year, an initial approval year, or your download date answers a different question.

On the manufacturer PDF checked for this article, the prescribing information says Revised 08/2026. The Medication Guide within the same file says Revised 05/2025. If you used the Medication Guide, identify it as patient material and keep its date. Searching a long PDF for “Revised” can find several legitimate answers.

For DailyMed, retain the Set ID and version in your source notes. Our selected record has Set ID e9481622-7cc6-418a-acb6-c5450daae9b0 and version 30. Its page says Updated April 17, 2025, while Labeling Archives lists May 5, 2025, as that version’s published date. The prescribing text itself says Revised 4/2025. Record those labels alongside the dates.

Build the AMA prescribing information citation

Concordia University Wisconsin’s pharmacy AMA 11 guide gives the sequence drug, document type, manufacturer, year, access date, and URL. It allows the document labels Package insert, Prescribing information, or Patient information. Choose the label that describes the material you read. The example uses a semicolon before the year.

The first entry below cites the manufacturer PDF as checked in October 2026. The second points to the selected DailyMed record. Notice that the year changes with the source URL. Replace the access date with the date of your own visit when preparing a paper.

Check DailyMed against the manufacturer document

Compare the title and company statements before comparing dates. For this pair, the prescribing information revisions differ. Keep the 2025 DailyMed reference when discussing that record, and cite the 2026 manufacturer file when using its text. Before replacing a link, check its revision date against the year you have already entered.

NLM warns that DailyMed’s in-use labeling may differ from the most recent FDA-approved labeling available through Drugs@FDA. A familiar host or matching brand name therefore cannot establish that two copies are identical. When a historical version matters, save the file and archive details used for your comparison.

Check the exact paragraph behind your statement before changing references to a newer label. This comparison establishes document identity only. It does not assess treatment effects or tell readers how to use the medicine.

Review imported metadata before using a generator

AMA Cite has no dedicated package insert form. Use the manual examples here as the final reference model. If you collect shared fields in the builder, check the output yourself, especially the document type and company. A URL import that names FDA or DailyMed has not established the manufacturer.

A Lexicomp drug monograph is a separate source with database-entry formatting. Keep its editorial identity when that is what you read. Before submitting, open every label reference once more and verify that its company, revision year, and destination still match your saved source.