APA
List the name of the pharmaceutical company first. Any APA reference list entry begins with the name of the person or company that is responsible for the content in the package insert. Typically this will be the name of the manufacturer or the drug, not an individual author. Place a period after the manufacturer's name. Example: Merck Sharp & Dohme Corp.
Add the year of publication in parentheses. The year of publication is typically listed at the bottom of the package insert. Type a space after the period and open parentheses. Type the year the package insert was published, then close the parentheses. Place a period after the closed parentheses. Example: Merck Sharp & Dohme Corp. (2011).
Provide the name of the drug and title of the package insert in italics. Type the full name of the drug followed by a colon. Then type the title of the package insert as stated at the top of the insert. Type the title in sentence-case, capitalizing only the first word and any proper nouns. Place a period at the end of the title. Example: Merck Sharp & Dohme Corp. (2011). Sylatron: Highlights of prescribing information.
Close your reference list entry with publication information. An APA reference list entry typically includes the location where the reference was published and the name of the publisher. Type the location of the drug company's headquarters, followed by a colon. For a package insert, the publisher is the pharmaceutical company, which has already been listed as the author. Instead of typing the name again, use the word "Author" to indicate that the author is also the publisher. Place a period at the end. Example: Merck Sharp & Dohme Corp. (2011). Sylatron: Highlights of prescribing information. Whitehouse Station, NJ: Author. APA Reference List Format: Manufacturer's name. (Year). Drug name: Title of package insert. Place of publication: Author.
Use the manufacturer's name and year for in-text citations. Whenever you quote or paraphrase from the package insert in the text of your paper, place a parenthetical citation at the end of the sentence. Type the name of the manufacturer followed by a comma and the year the package insert was published. Example: (Merck Sharp & Dohme Corp., 2011)
AMA/NLM
Start your entry with the name of the drug. Since the NLM style guide doesn't specify a format for package inserts, use the AMA format for NLM papers. Type the name of the drug, then a space, then include the words "package insert" in square brackets. Place a period after the closing brackets. Example: Albuterol [package insert].
Provide the place of publication. The next part of your citation is the place of publication, which typically is the location of the headquarters of the drug manufacturer. This location is typically listed on the package insert itself. Place a colon after the place of publication. Example: Albuterol [package insert]. West Roxbury, MA:
Close with the manufacturer's name and the year of publication. After the colon, type a space, then provide the name of the manufacturer of the drug. Place a semi-colon after the manufacturer's name. Add the year the package insert was published, then place a year. Example: Albuterol [package insert]. West Roxbury, MA: Armstrong Pharmaceuticals; 2007. NLM Reference List Format: Drug name [package insert]. Place of publication: Manufacturer's name; year of publication.
Check with your instructor or editor for in-text citation format. AMA papers use superscripted numbers for in-text citations that refer to the number of the entry in your reference list. The NLM guide doesn't recommend a specific format for in-text citations. Your instructor or editor can tell you what format they prefer. Some instructors may prefer a parenthetical in-text citation with the name of the drug followed by the year the insert was published.
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