How To Reference A Package Insert?

How to Reference a Package Insert in APA

  1. 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
  2. Add the year of publication in parentheses. The year of publication is typically listed at the bottom of the package insert.
  3. 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.

Please use the following format. Drug name. Place of publication: Manufacturer’s name; Year of publication. Albuterol.

How do you reference a package insert in an essay?

At the end of your paper you will need to list all references, including package inserts. Type the brand name of the product that you are referencing. Type the words ‘package insert’ enclosed by brackets. Type the city and the abbreviated state where the package insert was made.

How do you cite a package insert in AMA?

Name of medicine. U.S. Food and Drug Administration website. URL. Revised.

How do you cite a package insert Vancouver style?

Package insert

Place of publication: Publisher/Manufacturer; Year of publication. Note: Package inserts are the printed material about the use and effects of the product contained in the package. Lamasil. East Hanover (NJ): Sandoz Pharmaceuticals Corp; 1993.

Which drug reference contains package inserts?

Package inserts can be found in a reference book called the Physicians’ Desk Reference, better known as ‘the PDR.’ This book can be found in libraries on online. Package inserts can also be found on websites for companies that make prescription medications.

How do you cite a product in APA?

Cite a source with an author that provides information about the product within the text of your paper by writing this at the end of the sentence referring to the product: ‘(Last Name, Year of Publication).’ For example, write: ‘Coke beat Pepsi sales in 2010 (Jones, 2011).’

How do you cite product information in AMA?

Package inserts and prescribing information

Type of material. Company Name; year of publication. To indicate online access, add the accessed date and URL.

How do you cite a product label?

The basic APA format for citing product information as one of your references is as follows: Company name. (Year produced). Product name: Section of information.

How do you write a leaflet reference?

APA Referencing Guide — Leaflets, pamphlets, brochures

  1. Organisation(s). ( followed by full stop)
  2. (Year of publication). ( in round brackets, followed by full stop)
  3. Title (in italics)
  4. . ( e.g. leaflet, in square brackets, followed by full stop)
  5. Publisher. ( followed by full stop)

How do you reference patient information leaflet Vancouver?

Title: subtitle. Place of publication: Publisher; Year of publication .

How do I reference SmPC?

There will always be a ‘last updated’ date, which is the date you should give. Here is a suggested Harvard reference as an example: Mylan (2020) Acamprosate 333 mg Gastro-resistant Tablets SmPC. Available at: (Accessed: 4 December 2020).

How do you read package inserts?

The information in a package insert is written in technical language.

What Is in the Package Insert

  1. Highlights of Prescribing Information.
  2. Recent Major Changes.
  3. Indications and Usage.
  4. Dosage and Administration.
  5. Dosage Forms and Strengths.
  6. Contraindications.
  7. Warnings and Precautions.
  8. Adverse Reactions.

Is a package insert the same as prescribing information?

One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drug’s label, also known as the prescribing information or the package insert (PI).

How do you reference a piece of equipment?

The citation and reference use the manufacturer as author, and year of introduction of the product. Indicate in square brackets after the model’s name whether or if there is accompanying software required to use it.

Do you have to reference a product?

If you simply mention a product in text, you do not need a citation. However, when you use information you learned from a product’s label, instructions or a manual, you must cite that material.

How do you cite a kit?

To cite a primary-source document from a kit, follow the MLA format template. Begin by providing the title of the document or a description of it. Then list the title of the kit as the title of container and provide any pertinent publication details: Illumination from a fifteenth-century book of hours.

How do you reference a package insert in an essay?

At the end of your paper you will need to list all references, including package inserts. Type the brand name of the product that you are referencing. Type the words ‘package insert’ enclosed by brackets. Type the city and the abbreviated state where the package insert was made.

How to Cite a Package Insert

  1. Article to be downloaded article to be downloaded If you are writing a research paper in the medical profession, you may wish to include material from a medicine package insert that you have discovered.
  2. You will often include the name of the medication as well as information about who was responsible for the content of the insert and where it originated from in your reference.
  3. There are several citation styles to choose from, and the structure of your citation will alter depending on the style you’re using: American Psychological Association (APA), American Medical Association (AMA), or National Library of Medicine (NLM).
  1. 1 List the pharmaceutical company’s name first, followed by its address.
  2. To begin an APA reference list item, the author or firm that is responsible for the content of the package insert must be identified.
  3. Typically, the name of the producer or the medicine will be used instead of the name of an individual author.
  4. After the manufacturer’s name, a period should be used.
  1. As an illustration, the Merck Sharp & Dohme Corporation.
  1. 2 Place the year of publication in parentheses after the title.
  2. It is customary for package inserts to include a year of publication at the bottom of the insert.
  3. After the period, type a space and then open the parentheses.
  4. Close the parenthesis after you’ve typed in the year the package insert was first published.
  1. After the closing parenthesis, add a period at the end of the sentence.
  2. As an illustration, the Merck Sharp & Dohme Corporation (2011).
  • Promotional material
  • 3 Italicize the drug’s name and the title of the package insert to make them stand out. The complete name of the medication should be typed followed by a colon. Then input the title of the package insert, which should be the same as the title on the package. Titles should be written in sentence case, with just the first word and any proper nouns capitalized. After the title, add a period to the end of it. As an illustration, the Merck Sharp & Dohme Corporation (2011). Summary of prescription information for Sylatron.
  1. 3rd-party advertising Type in all capital letters the name of the medication and the title of the package insert.
  2. Insert a comma after the entire name of the medication.
  3. Finally, fill up your package insert’s title using the information that is printed on top of it.
  4. Type the title in sentence case, with just the first word and any proper nouns capitalized, and then press enter.
  1. After the title, add a period to the end.
  2. As an illustration, the pharmaceutical company Merck Sharp & Dohme Inc.
  3. (2011).
  4. Sylatron: Key points from the prescription instructions.
  • The following is the format for an APA reference list: manufacturer’s name. (Year). Title of the package insert containing the drug’s name. Author’s residence is the publication’s location. In-text citations should include the name of the manufacturer as well as the year of manufacturing. A parenthetical citation should be used at the end of each sentence whenever you quote or paraphrase from the package insert in your research report. The manufacturer’s name should be typed first, then followed by a comma, then the year the package insert was produced. As an illustration, (Merck Sharp & Dohme Corporation, 2011)
  1. 1 You should begin your entry with the name of the medication.
  2. Because the NLM style guide does not prescribe a format for package inserts, the American Medical Association (AMA) standard should be used for NLM publications.
  3. Type the drug’s name, followed by a space, and then put the words ″package insert″ in square brackets after that.
  4. After the closing brackets, a period should be placed after them.
  1. Take, for example, albuterol.
  1. 2 Indicate the location of the publication.
  2. The site of publication, which is often the location of the medication manufacturer’s headquarters, is the following section of your citation.
  3. In most cases, the packaging insert itself will include the address for this site.
  4. After the date and location of publishing, use a colon.
  1. For instance, Albuterol is available from West Roxbury, Massachusetts.
  1. 3 Finish by including the name of the maker and the year of publication.
  2. After the colon, type a space, and then enter the name of the pharmaceutical company that made the medicine.
  3. After the manufacturer’s name, a semi-colon should be used.
  4. After you’ve entered the year the package insert was published, you may insert a year.
  1. For example, Albuterol, manufactured by Armstrong Pharmaceuticals in West Roxbury, Massachusetts, was released in 2007.
  • The NLM Reference List is formatted as follows: drug name. The name of the manufacturer and the year of publishing are included in the book’s location. Consult with your teacher or editor to determine the proper structure for in-text citations. In-text citations in AMA articles are denoted by superscripted numerals, which correspond to the number of the corresponding entry in your reference list. The National Library of Medicine’s handbook does not provide a precise structure for in-text citations. Your instructor or editor will be able to inform you which format is preferred. Some teachers may prefer a parenthetical in-text citation that includes the name of the medicine followed by the year the insert was produced
  • however, this is not required.

Inquire about something There are 200 characters remaining. Include your email address so that you may be notified when this question has been resolved. Advertisement submissions are welcome. Thank you for submitting a suggestion for consideration!

About This Article

Thank you to all writers for contributing to this page, which has been read 27,198 times so far.

How to Cite a Package Insert

  1. The practice of citing sources from which you obtained information is a fundamental writing standard.
  2. Plagiarism is avoided by citing sources.
  3. You should utilize this phrase anytime you are passing along an idea or piece of information that is not your own.
  4. Included in this category is information you learn via movies, websites, interviews, and product packaging.
  1. Write down the information you intend to provide in your research report, followed by a description of how you obtained it.
  2. You must include all references, including packaging inserts, in your paper’s bibliography at the conclusion of it.
  3. Fill in the blanks with the brand name of the product that you are referring to.
  4. In the text box, type the words ″package insert″ surrounded by brackets.
  5. Fill in the blanks with the city and shortened state where the packaging insert was created.
  6. A comma should be used to separate the city from the state.

Type the name of the maker, followed by a semicolon, and the year the insert was manufactured, and then finish the citation with a period.Following the guidelines outlined in the ″Quick Reference Citation Format for the American Medical Association Manual of Style,″ a complete reference should look like this: ″Byetta.Amylin Pharmaceuticals, Inc., San Diego, CA; October 2007.″ In the event that you are using an online package insert, go to Step 5.The web URL where the online package insert may be found, as well as the date you visited the site to receive the information, should be typed on the following line.

Consider the following example: ″Accessed on January 13, 2010.″ To return to the previous screen, press ″Return,″ then ″Tab.″ Type the word ″Note″ followed by a colon to create a new note.Indicate whether or not the packaging insert is an official document, as well as the date on which it was last amended.The date of the most recent known alteration may be seen at the bottom of the document.

Library Guides: Reference Guide for Pharmacy Students: Referencing Guide – College of Pharmacy

  • The American Medical Association’s Manual of Style: A Guidance for Authors and Editors served as the basis for this guide. It is possible to include references or citations in a variety of methods
  • nevertheless, this guide will give a consistent structure that may be used throughout the professional program. Generally Acceptable Practices: References should be placed at the end of sentences or phrases as superscripts. Author names are listed with the author’s last name followed by initials, no periods are used in examples 1, 3, 5, and 8. As an illustration, Sheehan AH and Reed JB. The author’s last name should be spelt out in full at the end of the piece. Example Illingworth Plake is a town in the state of Kansas.
  • The spelling, abbreviations and style for numbers used in the original article title, book title, book chapters, or other material should be maintained.
  • In the titles of journal articles and chapter titles in books, capitalize only the first letter of the first word, (2) proper names, (3) names of clinical trials or study groups (eg, Community health worker home visits for adults with uncontrolled asthma: the HomeBASE Trial randomized clinical trial), and (4) abbreviations that are normally capitalized (eg, DNA, EEG, VDRL).
  • When writing journal and book titles, make sure to capitalize all of the important terms.
  • It is customary to set the year, followed by a semicolon, followed by the volume number and issue number (in parentheses), followed by a colon
  • the start page number, preceded by a hyphen, and the end page number, preceded by a period, without using spaces between them. Page numbers that are inclusive should not have any digits omitted. If the doi is available, it should be included. There should be no period after the doi, and the doi should be provided in lowercase characters with a colon and no spaces after the period after the doi. It is not necessary for the doi to be placed on its own line. The whole doi, beginning with the number 10, should be supplied. (doi:10.1111/acem.13311)
  • It is not necessary to use quote marks.
  • When feasible, refer to the most particular section (for example, reference the monograph inside the online database rather than the full database, or cite the chapter within a book).
See also:  How To Change Zip Code On Roku Tv?

Revised in July 2020 by AH Sheehan, VJ Killion, and JB Reed

Library Services: Vancouver Citation Style Guide: About Vancouver Style

  • When the International Committee of Medical Journal Editors proposed the Vancouver Style in 1978, it was quickly embraced by biomedical publishers all around the world, including the United States. It is mostly employed in the fields of health sciences and medicine. Use the drop-down menu on the left to get citation examples for a variety of different sites. Please keep in mind that there is currently no perfect consensus among guidelines on how to cite electronic sources. The examples offered in this tutorial are intended to serve as a guideline only. Whatever format you use, be sure that you are consistent throughout your work and that you check your instructor about recommended conventions before you begin. Your references should be referenced in the Vancouver Style in the following ways: consecutively in the order in which they occur in your paper, presentation, poster, or other piece of writing
  • Be distinguished from other material by the use of superscript Arabic numerals
  • Unless it contains essential information that cannot be obtained from a public source, avoid including ″personal communication″ unless it does so
  • in that case, the author should obtain written permission and confirmation of accuracy from the source of communication, which should be referenced in parenthesis in the text.
  • When there are six or fewer authors/editors, list all of them
  • when there are seven or more, list the first three and add ″et al.″
  • list authors with surnames first, followed by first and middle initials (if available)
  • list authors with surnames first, followed by first and middle initials (if available)
  • list authors with surnames first, followed by first and middle initials (if available)
  • Journal titles should be abbreviated according to the format available in the PubMed Journals Database.

How to Cite Packages

  • (You may report a problem with the content on this page by clicking here.) You’d want to post your stuff on R-bloggers, right? If you have a blog, go to this page
  • if you don’t, go to this page. What sources should I use?
  • What format should I use to reference it?
  • Blog articles from the past
  • Citing the statistical packages, modules, and softwares that you used for your analysis is important, both from a reproducibility standpoint (statistical routines are frequently implemented in different ways by different packages, which could explain slight discrepancies in the results) and from a citation standpoint. In addition to protecting yourself by being clear about what you have discovered while doing what you have done), saying ″I did this using this function from that package version 1.2.3″ is a way of acknowledging the work and time that people have put into creating tools for others (as well as their own) (sometimes at the expense of their own research). That’s fantastic, but how do you really reference them?
  • Should I list all of the packages I used, or just the ones I used the most?

In an ideal situation, you should include all of the packages that you utilized. However, it isn’t very diegetic. Therefore, the following is what I would recommend:

  1. Cite the main / important packages in the manuscript
  1. The programs that were crucial to your specific study (i.e., the ones that provided you with the results that you published) should be included in this list, rather than data manipulation tools (even though these are as much important).
  2. As an illustration: The statistical analyses were carried out using R 3.5.0 (R Core Team, 2018), the rstanarm (v2.13.1; Gabry & Goodrich, 2016) and the psycho (v0.3.4; Makowski, 2018) packages, and the rstanarm package was used to generate the results.
  3. Supplementary Materials provide the complete, reproducible code for this project.
  1. Present everything in Supplementary Materials
  • Afterwards, in the Supplementary Materials section, you list the packages and functions that you employed. Furthermore, the sessionInfo() function in R allows you to include (often at the conclusion of a script) every package and its version that has been used. It might be difficult to locate the correct citation information at some times. In R, this process is made very simple
  • you simply execute the citation function (″packagename″). For example, consider the expression citation(″dplyr″): In publications, Hadley Wickham, Romain François, Lionel Henry, and Kirill Müller should be cited as the authors of dplyr (2018). dplyr is a data manipulation grammar written in Python. The R package is currently at version 0.7.6. @Manual is a BibTeX item for LaTeX users that contains the following information: title=author=year=note=url=, @Manual Other programming languages, such as Python or Julia, may be a bit more difficult to learn, but a short search on Google (or GitHub) should give you with all of the knowledge you need to get started (version, authors, date). It’s preferable to have a somewhat incomplete citation than to have no citation at all, in most cases. There will be no more ANOVA reporting mistakes
  • Participants-wise Standardization vs Variable-wise Standardization
  • Formatted Correlation with Effect Size
  • Creating a Reference Grid from your data for the purpose of visualizing Machine Learning Models
  • Copying and pasting t-tests directly into manuscripts
  • Simple APA-formatted Bayesian Correlation
  • Fancy Plot (with Posterior Samples) for Bayesian Regressions
  • Easy APA-formatted Bayesian Correlation
  • In factor analysis, how many factors should be retained
  • beautiful and powerful correlation tables
  • formatting and interpreting Linear Mixed Models
  • and more.
  • How to do ANOVAs using Repeated Measures
  • Standardize (Z-score) a dataframe
  • Compute Signal Detection Theory Indices
  • Install R, R Studio, and psycho
  • Compute Signal Detection Theory Indices

How to Cite Product Information in APA Style

  1. Jeff Hume-Pratuch contributed to this article.
  2. Greetings, Fashion Gurus!
  3. The usage of some prescription and over-the-counter medications is the subject of a paper I’m writing.
  4. My information came from the small packaging inserts that are included in the box or bag that you receive when you pick up your prescription.
  1. I’m not sure how to properly reference it.
  2. Help!
  3. —A Philadelphia Pharmacologist who is dissatisfied Dear Frustrated, Do Not Worry!
  4. We can figure out how to overcome this citation problem by asking ourselves four of our favorite questions: Who?
  5. When?
  6. What?

Where?Consider the following scenario: you’re researching head lice treatments and you need to quote the pharmaceutical insert for Ulesfia lotion.Who is in charge of the content of the package insert and how does this happen?Because the distributor, Shionogi Pharma, is named on the insert, we’ll place their name in the author position (in accordance with our policy of ″cite what you see″).

What year did it come into being? The date on the insert is 2010, thus that will be the date in the location of the insert.

What is the name of the document? In addition to being uninformative, the title of the insert (Highlights of Prescribing Information) should be sufficient to convey the necessary information to the reader.

What was the source of the problem? Because the publisher and author of the package insert are the same person, we’ll put the author’s information in the publisher position to avoid confusion.

  1. And here’s something to think about: Shionogi Pharma is a pharmaceutical company based in Japan (2010).
  2. The most important points to remember about Ulesfia lotion’s prescribed instructions.
  3. Author’s residence in Atlanta, Georgia.
  4. Citation in the text: (Shionogi Pharma, 2010) In the event that you obtained the prescription information from the manufacturer’s website (which also offers downloadable coloring pages of ″Louie the Louse″ to keep your children occupied throughout the 10-minute application procedure), you would quote it as follows: Shionogi Pharma is a pharmaceutical company based in Japan (2010).
  1. The most important points to remember about Ulesfia lotion’s prescribed instructions.
  2. This information was obtained from Ulesfia Prescribing Information.pdf.
  3. Citation in the text: (Shionogi Pharma, 2010) For scholarly purposes, on the other hand, you could have obtained the product insert from the FDA website, in which case your citation might be something like this: Shionogi Pharmaceutical (2010).
  4. The most important points to remember about Ulesfia lotion’s prescribed instructions.
  5. The information was obtained from cder/drugsatfda/index.cfm.
  6. This approach may be used to cite any type of product information, including packaging inserts for small appliances, hand tools, and adhesive tiles, as well as product information on the Internet.

NET Core – Adding References to Library

  1. Adding references to your library will be covered in detail in this chapter, so stay tuned.
  2. Adding references to a library is similar to adding references to other projects, such as a console project or a UWP project, in that it requires no additional effort.
  3. You can now see that the PCL project contains some default references, which is a good thing.
  4. You can also include more references based on the requirements of your application.
  1. In addition to the project.json file, you may find it in the PCL library.
  2. ″supports″: ″netstandard1.3″; ″dependencies″: ″NETStandard.Library″: ″1.6.0″; ″Microsoft.NETCore.Portable.Compatibility″: ″1.0.1″; ″frameworks″: ″netstandard1.3″; ″dependencies″: ″NETStandard.Library″: ″1.6.0″; ″Microsoft.NETCore.Portable.Compatibility″: ″1.0.1″; ″ When adding references to your library, you may do so by putting the information straight into the project.json file.
  3. As you can see in the following code, we have included certain references under the dependencies section, which you can read more about here.
  4. Supported libraries and dependencies include: ″NETStandard.Library″: ″1.6.0,″ ″Microsoft.NETCore.Portable.Compatibility″: ″1.0.1,″ ″System.Runtime.Serialization.Json″: ″4.0.3,″ ″Microsoft.EntityFrameworkCore″: ″1.1.0,″ and ″netstandard1.3.″ Frameworks include ″netstandard1.3,″ ″netstandard1.4,″ and ″netstandard1.5.″ Let’s save this file now, and you’ll notice that references have been added to your library as a result.
  5. The NuGet Package Manager is another means of including references to your library in your project.
  6. Right-click on the StringLibrary (Portable) project and select Manage NuGet Packages…

to complete the process.On the Browse tab, you may search for any NuGet package; for example, let’s assume we want to add the ″System.Runtime.Serialization.Primitives″ package to our project.To begin installing, click the Install button, which brings up the following screen.Now, press the OK button to confirm your action.

Finally, click on the I Accept button to begin the installation of this NuGet package on your computer.Once the installation process is complete, you will see that the ″System.Runtime.Serialization.Primitives″ NuGet package has been added to your library’s Resources section.

How do I cite a drug package insert?

  1. The following are the components of a citation for a package insert in the American Medical Association style: (note that you may wish to include a trademark symbol if appropriate for the drug name).
  2. Please understand that the year of publication relates to the most recent edition of the medicine package insert, which may be obtained on the FDA website: Name of the medication is cited as the source.
  3. Publisher’s address; year of publication/revision; place of publishing.
  4. As an illustration:

Risperdal (risperidone). The Janssen Pharmaceutical Companies, Titusville, New Jersey; 2019.

Manufacturer’s webpage on the Food and Drug Administration. The name of the medication. The Food and Drug Administration of the United States has a website. URL. Revised. Accessed. As an illustration:

Pharmacies owned by the Janssen Pharmaceutical Companies. Risperdal (risperidone). The Food and Drug Administration of the United States has a website. This version was updated in January 2019. This page was last updated on May 20, 2019.

  1. EndNote Formatting You may manually generate a package insert citation in EndNote by selecting References and then New Reference from the References menu.
  2. For the reference type, select Journal Article as the source.
  3. The citation should be entered into the Title field of the EndNote citation that you are constructing.
  4. When you’re finished, save the citation and then use it just like any other EndNote reference in the future.

Library Guides: Vancouver referencing style: Pamphlets / Brochures / Package inserts

Skip to Main Content

Pamphlet / Brochure

Elements of the citation Author. Title of brochure/pamphlet. Place of publication: Publisher; Year of publication.

The Pharmaceutical Society of Australia has issued a statement on medications and driving. The Pharmaceutical Society of Australia published a book in Sydney in 1998.

In-text As listed in the pamphlet by the.1
EndNote reference type Pamphlet Type of Work field: enter – pamphlet

Package insert

Elements of the citation Name of medicine. Place of publication: Publisher/Manufacturer; Year of publication. Note: Package inserts are the printed material about the use and effects of the product contained in the package.

Sandoz Pharmaceuticals Corporation published Lamasil in East Hanover, New Jersey in 1993.

In-text One of the side effects listed.(2)
EndNote reference type Pamphlet Type of Work field – enter – package insert

Package insert online

Elements of the citation Name of medicine. Place of publication: Publisher/Manufacturer; Year of publication. Available from: URL

Sandoz Pharmaceuticals Corp., East Hanover, New Jersey, 1993. Lamasil.

In-text Ventolin3 usage.
EndNote reference type Pamphlet Year field: enter – Publication year. Available from: URL. eg. 2017 . Available from:_inhaler_cmi_au_008_approved.pdf Type of Work field: enter – package insert on the Internet

How to Read A Package Insert

  1. When you go to the pharmacy to fill a prescription, you are generally given a brief overview of the drug’s characteristics and side effects.
  2. You may also receive a ″package insert,″ which has more specific information.
  3. The information included in the package insert has been authorized by the United States Food and Drug Administration (FDA) on the basis of research (clinical trials) in which the drug was administered to participants.
  4. Package inserts are accessible for all prescription drugs that have been authorized by the Food and Drug Administration.
  1. For certain herbal medicines and dietary supplements, similar information is accessible as it is for prescription and non-prescription medications.
  2. In a reference book known as the Physicians’ Desk Reference, sometimes known as ″the PDR,″ you may find information about package inserts.
  3. This book is available in libraries and on the internet.
  4. Package inserts are also available on the websites of pharmaceutical businesses that manufacture prescription drugs.

The following sections can be found in all package inserts

Important Safety Information:

This section will include a box highlighting any special safety information regarding the medication. Detailed descriptions of the facts may be found further down in the prescription information.

Indications and Usage:

  1. This section is a list of the indications (or uses) for which the medicine has been authorized by the FDA.
  2. The illnesses, or in this case, the forms of epilepsy, that are mentioned are those for which suitable research investigations were conducted prior to the medicine being approved.
  3. Please don’t be startled if your particular form of epilepsy isn’t included.
  4. Using pharmaceuticals for kinds of epilepsy or other causes that have not been specified in this section by the FDA is quite widespread (and legal) among doctors and other prescribing professionals (i.e., health care professionals who are authorized to write prescriptions for medications).
  1. This is referred to as ″off-label″ usage of a medication.
  2. This is typical for less prevalent kinds of epilepsy or seizures, as well as for the administration of a medication to youngsters.
  3. It is possible that doing those trials before the FDA authorizes the medicine for new applications may be more difficult or expensive.
  4. When a prescription drug is used ″off-label,″ the prescriber will study additional research, experiences with other patients, and the opinions of experts in the area before making the decision.
  5. His or her professional opinion regarding whether or not the medication is likely to be beneficial is then used to determine whether or not it should be prescribed.
  6. Please keep in mind that certain insurance companies may refuse to give prescription coverage or may refuse to pay for a medication that is supplied ″off-label.″ Alternatively, they may just give partial coverage, in which case you may be required to pay a higher price for the medication.

Some seizure medications are also used to treat illnesses other than epilepsy, such as migraines.Some medications, for example, may also be used to treat pain, migraine headaches, mental disorders, and other issues, among others.When treating you for another disease in addition to epilepsy, your doctor may evaluate if the same medicine could be used to treat both conditions simultaneously.

Dosage and Administration:

  1. This section contains information on the suggested doses of the medication.
  2. Typically, it will advise on how to begin administering the medication (including how much to give at first), followed by instructions on how to increase the dose to an effective level.
  3. Many times, your doctor will recommend that you begin taking the medication at a lesser amount than that prescribed above and gradually raise the dosage to reduce the likelihood of experiencing adverse effects.
  4. Depending on whether the medication is indicated for more than one usage, you may find different sections for each use.
  1. Separate instructions may also be included on how to administer the medication to youngsters, the elderly, or individuals suffering from certain medical conditions.
  2. If your doctor has recommended a regimen that is significantly different from what you read in this section, inquire as to why the difference exists.
  3. A number of factors particular to you, such as other medical conditions or drugs, may dictate that you need to take a different dose or take it in a different way than normal.
  4. Continue to follow your doctor’s instructions and communicate with him or her about how you are feeling while taking the medication.

Dosage Strength and Forms:

This section contains a list of the medication’s dose and the form in which it is available (tablet, capsule, or liquid).


Contraindications are instances in which a medication should not be taken and should be avoided.In some cases, a medication should not be provided to someone who has previously experienced an allergic reaction to the same prescription or a medication that is similar, or to someone who is now taking another medication that interacts with the medication in a negative way.This section may also advise doctors not to administer the medication to those who have particular medical problems if they are at higher risk of experiencing hazardous adverse effects from the medication.In the case of Depakote, for example, the box insert cautions that it should not be taken by persons who have liver illness.If you have any other medical conditions, it is critical that you review this section.

However, you should always discuss any information with your own physician.

Warnings and Precautions:

This section highlights the potentially life-threatening adverse effects that may occur in patients who use this medication.If a box warning refers to problems that are very serious or life-threatening, more information will be included here as well.You should pay close attention to these cautions so that you can identify any symptoms that might indicate a significant condition.However, do not be excessively concerned.Consult with your doctor first to see how this information applies to you and what you should be on the lookout for.

Precautions offer instructions on how to take the drug in the safest and most effective manner possible.It provides the clinician with information about the sorts of patients that require close monitoring.Here you can find information about any laboratory tests that should be conducted before or during the period that the drug is being taken.

It is possible that this section will include a list of activities (such as driving) that require extra vigilance while the medication is being used.The information about pregnancy can also be found in this area from time to time.The warning section may also state that you should not take this medication with a certain meal or other product (such as an antacid).This section should be reviewed to determine whether any medications, foods, or other goods that you use on a daily basis are included on the list.

Adverse Reactions:

This section contains a comprehensive list of all of the adverse effects that have been recorded in persons who have taken this medication while it was being evaluated.These side effects are often classified according to the bodily system that has been impacted, as well as the number of persons who have reported them.During clinical trials, side effects that were labeled as ″often″ or ″common″ may have occurred in just a tiny fraction of patients who took the medicine.The package inserts compare the incidence of adverse effects in individuals who took a placebo or inactive medicine to those who received the active drug.The active drug was used in the comparison.

They will also report on the frequency with which a side effect has been recorded in any sort of trial or after the drug has been approved for marketing purposes.Because they contain so many problems ranging from small to life-threatening, these lists of ″adverse occurrences″ might be frightening to read because they contain so many difficulties.Keep in mind that this section contains information on anything that happened to or was reported by persons who were taking the medication, regardless of whether or not the event was related to or caused by the medication.

You may suffer some of the adverse effects on the list, or none at all, depending on your circumstances.Even the side effects that are mentioned as the most common do not occur in every person who takes the medication.Additionally, keep in mind that frequently, seizure medications are evaluated in persons who are currently taking other seizure medications as well.If you are using a different seizure medication, you may notice a difference in the side effects.

The likelihood that you may have some of these adverse effects is low, as they are uncommon or infrequent.However, if they are also discussed under the headings Warnings or Precautions, you should discuss them with your doctor.

Drug Interactions

In the insert, one of the most essential sections is the section titled Drug Interactions, which describes the effects that a medication may have on other prescription and over the counter drugs, as well as food and beverages.These additional medications may interact with the seizure medication, or the seizure medication may interact with your non-seizure medications, causing difficulties.If you are taking any of the medications on this list, you should talk to your doctor and pharmacist about all of your medications.

Use in Specific Populations

This section contains information about potential difficulties that may arise if the medicine is taken during pregnancy or while nursing.If you are considering becoming pregnant, it is recommended that you discuss them with your doctor.Results of Pregnancy Registries of seizure drugs may also provide him or her with further information on the medications in question.Always keep in mind that most women have healthy kids regardless of the medication they use throughout their pregnancy.This section will also discuss the usage of the drug in children, the elderly, and persons who have special health concerns that might have an impact on the use of the medication, among other things.

Drug Abuse and Dependence

This section informs the reader whether the medication has the potential to be abused or to induce psychological or physical dependence.The box inserts for the majority of seizure medications state that there is no evidence of abuse potential or dependency, or that the medication has not been evaluated in human subjects, respectively.Drug dependency can occur with seizure medications belonging to the barbiturate or benzodiazepine classes (such as phenobarbital, Mysoline (primidone), and Klonopin (clonazepam).If you have a history of drug dependence, you may want to read this section to discover if this medication has the potential to be a problem for you before using it.If you’ve been taking a medication that has the potential to create dependency, never stop taking it suddenly.

Under the supervision of a medical professional, the dose should be gradually reduced.


This section describes the possible consequences of a large dose of the medication, as well as how they should be addressed in the event of an overdose. This type of information is mostly beneficial to medical professionals. If you believe that you or someone else has taken an excessive amount of medicine, call a poison control center or go to the nearest emergency hospital straight away.


Here is where you will find the chemical name of the medicine, as well as a diagram displaying the individual atoms and molecules included inside the drug.It specifies the form in which it is accessible, such as pills, capsules, or liquid, as well as the doses that are offered.It also includes a list of all non-active substances, such as fillers, artificial colors, and flavorings, among other things.If you have food sensitivities, you should inquire as to what additional ingredients are utilized in the production of this medication.

Clinical Pharmacology:

A significant amount of the material in this section may be difficult to comprehend.Phamacodynamics, pharmacokinetics, and bioavailability are some of the terms you’ll come across.Essentially, this part describes how the drug functions in the body, including how it is absorbed and removed, as well as how it functions at different dose levels.If there are variances in how it operates for other groups of individuals, such as children, the elderly, women, or people of different ethnicities, these will be described in this section.Especially if you have a medical condition such as kidney or liver disease, this is one of the areas your doctor will review before choosing whether or not to prescribe this sort of medication for you, and if so, how much and when to give it to you (and how often).

Nonclinical Toxicology:

This section highlights animal studies of the medicine that are essential in determining how it could be used in people in the future.In certain cases, it may provide information about possible concerns that cannot be investigated in people.For example, whether or not a medication has the potential to cause cancer, reproductive issues, or other health concerns.It is not possible to gather this sort of information from examining people for short periods of time.

Clinical Studies:

This section discusses the findings of clinical trials that demonstrate how efficient or beneficial the medicine is, as well as any dangers or adverse effects that may arise.The information in this part can assist clinicians in understanding how the medicine works when it is compared to a placebo or inactive drug, how it works when it is administered alone, and how it works when used in combination with other seizure drugs.

How Supplied, Storage and Handling:

This section contains all of the many dosage forms of this medication, which may include tablets or capsules in a variety of sizes and shapes, as well as liquids.The color, form, and marks of each one are explained in detail, allowing you to be certain of which one you are taking.Does the liquid you have need to be shaken before it can be used, or is it a suspension that can be used immediately?In addition, storage instructions are provided in this section.This is where you will find out whether or not you should store the liquid form in the refrigerator.

It also tells you whether or not you should keep your medicines away from heat, light, and moisture.If you pick up your prescription from the pharmacy on a hot day, don’t leave it in the car while you run other errands since there’s usually a warning against exposing the drug to temperatures higher than 30oC (86oF).

Patient Counseling Information

Listed below are all of the several dosage forms of this medication, including tablets or capsules in a variety of sizes and maybe liquids, that are currently on the market.The color, form, and characteristics of each one are detailed in detail, allowing you to be certain of which one you are picking.What is a suspension, and how do you know whether you have a liquid you need to shake before using it?Instructions on how to store your items are also included in this section.The answer to whether or not to keep the liquid form refrigerated will be revealed in this section.

It also tells you whether or not you should keep your medicines away from heat, light, or humidity.If you pick up your prescription from the pharmacy on a hot day, don’t leave it in the car while you run other errands since there’s usually a warning against exposing the drug to temperatures above 30oC (86oF).

How to Cite a Product With APA

American Psychological Association (APA) style guide: This guide provides information on how to properly attribute other writers, websites, and publications that you consult when writing your work.Citing items in the American Psychological Association (APA) style is as simple as giving the product name.The American Psychological Association will help you through the process of referencing particular facts about the product, such as its components or sales figures, or information about its applications or controversies surrounding the product.

Step 1

Obtain all of the pertinent facts regarding the product that will be discussed in your article.Collect the website address, publication title, journal or newspaper article title containing information about the product mentioned in your paper, as well as any other relevant information about the product you discuss in your paper.In order to create your citation, you must first locate the author(s), publication date, and publisher information.

Step 2

Cite a source with an author who provides information about the product within the text of your paper by writing the following at the end of the sentence referring to the product: ″(Last Name, Year of Publication).″ Cite a source with an author who provides information about the product within the text of your paper by writing the following: ″(Last Name, Year of Publication).″ In the case of Coca-Cola, you may write: ″Coke sales outpaced Pepsi sales in 2010 (Jones, 2011).″ In text, cite a reference to product information that does not include an author by using the syntax ″(″Title of Article,″ ″Year of Publication″).″ Include a page number when citing a direct quote in your text, as follows: ″Last Name or Article Title (Year of Publication) discovered that ″″ (p.Page Number).″

Step 3

Please provide citations for the works that you cite in your article’s body in a reference or ″Works Cited″ section at the conclusion of your paper.List all of the entries alphabetically by the last name of the author, or by the title of the article if there is no author.Fill in the blanks with the following information for print papers that contain product information: ″Last name and first initial of the author.(Year in which the book was published.) The title of an article or a document.Italicize the title of the journal or publication.

Publisher is responsible for the publication.″

Step 4

As an example, you might use the following reference to product information that you found online, such as on the website of the manufacturer or distributor: ″Last name and first initial of the author (Date of Publication).The title of the article or the URL of the online page.The information was obtained from the URL website address.″ The following is an example of how to cite an online newspaper article: ″Last name and first initial of the author (Year of Publication).The title of the article.The title of the newspaper is in italics.

The information was obtained from the URL website address.″

Research Guides: AMA Style (11th ed): Citing Your Sources: Home

It was the editors of the Journal of the American Medical Association (JAMA) that came up with the American Medical Association (AMA) style (JAMA).The American Medical Association (AMA) style manual outlines the writing and citation styles for scientific publications in medicine.The American Medical Association style is internationally recognized and is used across a wide range of disciplines in the health sciences.The American Medical Association Manual of Style was first published in 1963, and it is currently in its eleventh revision (2020).This book, which condenses approximately 200 pages of print information on citing and referring in AMA Style into a few basic and common citation styles, offers some basic and common citation styles.

Consult the complete 1200-page American Medical Association Manual of Style for much more information on citing, referencing, writing, and manuscript styling.For example, in contrast to other publication guidelines, the American Medical Association Manual of Style includes a range of permissible citation methods, explains the purpose of each practice, and allows the writer/editor to select choices that are appropriate for their unique project.Because of this element of choice, the only individuals who can determine if an AMA structured citation is ″right″ are the person who is marking your citations as part of your schoolwork or the editors who are assessing your article submission.

The examples provided here are limited to the most fundamental and general AMA citation requirements.If you’re writing for a class or for publication, make sure to adhere to any specific guidelines that have been supplied to you.If you haven’t been given any particular instructions other than ″use AMA style,″ attempt to think about what style decisions you might make to correspond to the ultimate aims of any citation style, such as the following: provide evidence to the reader that you chose an accurate, reputable, and authoritative source for this fact, quotation, or thought, and provide directions to the reader on how to locate the precise source you are citing Examine this guide for widely used reference styles; then go through the whole Manual for all styles and manuscript styling requirements.

How to Cite a Product Label in APA Format

If you’re writing on manufacturing procedures or nutrition, you may need to include product information in your article as a source of knowledge. In the case that you’re working with the American Psychological Association (APA) style, you already have a template that you may use to reference product data.

Reference List Citation

The following is the fundamental APA structure for mentioning product information as one of your sources in your paper: The name of the company.(Year in which the product was made.) Section of information is the name of the product.Author is the location of the company.Consider the case of General Mills.(2015).

Nutritional information about Cheerios.Author’s residence in Minneapolis, Minnesota.Replace the firm location information with ″Retrieved from″ and the uniform resource locator, or URL, if you are obtaining product information from a website instead: The Quaker Oats Company is a multinational corporation headquartered in the United States.

(2015).Aunt Jemima’s nutritional information are provided.This information was obtained from:

In-Text Citation

When citing the product label reference in the text of your work, utilize an in-text citation. In this section, the manufacturer’s name and the year of manufacturing are included in parenthetical language. General Mills (General Mills, 2015) (The Quaker Oats Company, 2015)

LibGuides: Pharmacy: Referencing – Pharmacy

The majority of Pharmacy references may be divided into three categories: books/chapters, journal articles, and online sites. However, there are two important sources of pharmacy information that might be confusing.

British National Formulary (BNF/BNFC)

The most important thing to remember about this is that BNF is not the author!The Joint Formulary Committee is responsible for the creation of the BNF.It is necessary to include them as authors in both your in-text citations (if you are using Harvard style) and reference list.This is true regardless of whether you are using a printed copy or have electronic access to BNF..If you are utilizing a print copy (or an electronic version) of the BNF, be sure to specify which edition you are using in your citation.

If you are utilizing electronic access through the NHS, be sure to include the date on which you accessed the specific page in your report.This is critical owing to the frequency with which the BNF is updated.Example: Here is a reference for the entire print BNF in Harvard format (with in mind that you will almost certainly be referring to a particular entry): The Joint Formulary Committee (2021) will publish the British National Formulary, which will be available from March to September 2021.

The BMJ Group and Pharmaceutical Press are based in London.As well as in Vancouver format: Joint Formulary Committee, British National Formulary, 81 (March-September 2021), Joint Formulary Committee.1738 pages, published by the BMJ Group and Pharmaceutical Press in London in 2021.

Electronic Medicines Compendium (EMC/

If you obtain a Patient Information Leaflet or a Summary of Product Characteristics through the EMC, keep in mind that the EMC is a website, not a creator of the document you are seeing.The author is the pharmaceutical business that manufactures the medicine, which will be identified on the website.Always keep in mind that a ″last updated″ date will appear, which is the date you should provide.As an illustration, here is a Harvard reference that has been suggested: Mylan (2020) Acamprosate 333 mg Gastro-resistant Tablets SmPC is a medication that is available at the following locations: (Accessed: 4 December 2020).Furthermore, on the same page is a Vancouver-style reference: Mylan.

Acamprosate 333 mg Gastro-resistant Tablets SmPC.2020.Available from the following sources: Clinical recommendations from NICE are cited in the same manner as web pages are (since they are published on the internet), but they should include the guideline number in addition to the title of the document.

The date that is provided should be the date that was ″most recently updated.″ It is also necessary to specify the date on which you accessed the guideline, as they are subject to change.Acute coronary syndromes (National Institute for Health and Care Excellence, 2020) is an example of the Harvard (Cite Them Right) citation style.NG185.You may find it at: (Accessed: 7 December 2020).

In the same vein, the National Institute for Health and Care Excellence is a Vancouver-style reference.2019; NG185; Acute coronary syndromes, 2020; Available from the following sources:

How to Read a Package Insert

  • What Is in the Package Insert
  • How Should I Use the Package Insert
  • What Is in the Package Insert

Whenever you begin taking, or are considering taking, a new HIV medication, your health care practitioner will go over some fundamental facts with you.The prescription is filled and you are given extra written information, which is standard practice.Depending on the pharmacy, you may only receive a quick summary or you may receive a highly extensive ″package insert″ that contains information given by the medicine manufacturer and authorized by the United States Food and Drug Administration (FDA).Each nation or area has its own regulatory organization that oversees the distribution of medications and is responsible for providing the information that customers (users) get along with their prescriptions.The Central Drugs Standard Control Organization (CDSCO) is responsible for this in India (CDSCO).

In Europe, the European Medicines Agency (EMA) is in charge of the package insert, which is referred to as the patient information leaflet in this country (PIL).Prescription drug package inserts (often referred to as Prescribing Information) are accessible for all prescription medications approved by the Food and Drug Administration (FDA).Information about nonprescription medications, as well as herbal medicines and nutritional supplements, is provided on the same basis as for prescription medications.

In most cases, you can find the package insert online on the drug manufacturer’s website.It is also available in a reference book called the Physicians’ Desk Reference (PDR, which also stands for Prescribers’ Digital Reference, the book’s online version), which you may be able to find at your local library or that you can access online.

What Is in the Package Insert

  • The information contained in a package insert is written in a specialized technical style. It is typically exceedingly extensive and difficult to comprehend in its entirety. However, it is a good idea to go through it because it contains crucial information about the medicine that should not be overlooked. Please consult with your health care practitioner or pharmacist if you have any queries. It’s also possible to speak with an instructor at your local AIDS care agency. Every drug’s package insert follows a standard format that is followed by all of them. In the following parts, which occur in this order: after some identifying information, such as a medicine’s brand name, generic name, and the year when the drug was initially authorized by the FDA, most to all of the following sections appear: Precautions and Warnings
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Drug Interactions
  • Use in Specific Populations
  • Overdosage
  • Description
  • Clinical Pharmacology
  • Nonclinical Toxicology
  • Clinical Studies
  • References
  • How supplied/storage and handling information
  • Patient Counseling information

When it comes to HIV medications, certain package inserts begin with ″Boxed Warnings,″ which emphasize particularly significant (and even life-threatening) adverse effects that have been recorded but are extremely rare.The generic name of the medication will be used in the package insert the majority of the time (the scientific name for its main ingredient or ingredients).Patients are accustomed to knowing a medicine by its brand name (the name under which it is sold), thus this might be perplexing for them.Also keep in mind that the brand name of a medicine may change from one country to the next.If you have any queries about HIV medications in the United States, you can consult our HIV Drug Chart/Overview, which covers each medication by brand and generic name.

It should be able to find the drug’s various names by conducting a simple search online using the name you have (e.g., if what you have is the generic name, most websites that mention the drug will also list its brand name and possible abbreviations).While there is no specific section of the package insert dedicated solely to women, information that is relevant to women (for example, indications for use in pregnant or bre

Leave a Reply

Your email address will not be published.