The paperwork that comes with a prescription is easy to treat as one pile of fine print from the drug company, and easy for you to put down unread. The pile has several authors and several intended readers. For every prescription medicine approved by the U.S. Food and Drug Administration, or FDA, the drug company proposes the labeling, and the FDA reviews it and approves it only if it is acceptable. That labeling includes a document for health care professionals, the information printed on the carton or container and, for many medicines but not all, pages for patients and caregivers. A pharmacy bag can also hold a leaflet written by someone other than the drug company, and the bottle can carry colored warning stickers.
Which of the papers was written for you
The drug company's papers written for you, where your medicine has them, carry one of three names: a Medication Guide, Instructions for Use, or a Patient Package Insert, which may also be called Patient Information. A sheet whose headings say Prescribing Information is for health care professionals, such as doctors, nurse practitioners, physician assistants, pharmacists and nurses. So if that sheet has been hard going, you have been reading a document addressed to someone else.
| Paper | Written for | Written by | Approved by the FDA |
|---|---|---|---|
| Prescribing Information | Health care professionals | The drug company | Yes |
| Medication Guide | Patients and caregivers | The drug company | Yes |
| Patient Package Insert, or Patient Information | Patients and caregivers | The drug company | Yes |
| Instructions for Use | Patients and caregivers using a medicine with complicated or detailed instructions | The drug company | Yes, though some are not approved |
| Consumer medication information | Patients and caregivers | A person or organization other than the drug company | No, and the drug company does not review it either |
A Medication Guide is required when it could help prevent serious side effects, when the medicine has serious side effects patients need to be made aware of, or when following the directions is important for the medicine's effectiveness. Any one of those is enough, so a Medication Guide in the bag does not mean all three apply to your medicine. Where a medicine has one, it must be given to you whenever the medicine is dispensed.
Patient Package Inserts are required for birth control pills and for medicines that contain estrogen, and for those they must be given to you whenever the medicine is dispensed. For other medicines a drug company may submit one for approval, and it does not have to be given to each patient. Instructions for Use come with medicines that have complicated or detailed instructions, such as one used with an autoinjector, a patch or a syringe, or one that has to be mixed before use, and they are handed over when the medicine is dispensed. The steps in them are written for that medicine, so ask the pharmacist who filled the prescription, or the person who prescribed it, about any step you are unsure of.
A leaflet carrying none of those names may be consumer medication information, written for patients and caregivers by a person or organization other than the drug company and meant to be given to you when you receive a prescription. Neither the FDA nor the drug company reviews it. If that is what the leaflet is, it is not part of the drug company's labeling: it comes from a different author, and only the drug company's labeling goes through FDA review. If two papers in the bag seem to disagree, ask your pharmacist which one applies.
Not every prescription medicine has a Medication Guide, a Patient Package Insert or Instructions for Use, so a bag with none of them in it may simply mean your medicine has none. To find out, ask your pharmacist whether there is a Medication Guide or other patient information for this medicine.
What the black box on the page means
A Boxed Warning, sometimes known as a black-box warning, is set in bold type inside a single black line, and it holds contraindications, the situations in which the medicine must not be used, or warnings about serious side effects that may lead to death or serious injury. It is placed prominently at the beginning of the Prescribing Information, so it sits on the sheet written for health care professionals.
It is the FDA's most prominent warning, and it can arrive together with a page written for you on the same subject. For example, when the FDA required a Boxed Warning about serious mental health side effects to be added to the prescribing information of montelukast, an asthma and allergy medicine, in 2020, it also required a new patient Medication Guide. That guide explains the mental health risks along with the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for.
If your medicine has a Medication Guide, it may cover the same subject in words meant for you. If a Boxed Warning leaves you unsure about starting the medicine, ask the prescriber whether the warning bears on you before you take it.
How much to rely on the stickers on the bottle
The stickers on the bottle are cautions to read and follow, and any sticker that leaves you unsure is a question for your pharmacist. They are prescription warning labels, small colored stickers placed beside the drug label, each carrying a caution about taking the medicine safely, such as "take with food" or "limit time in sunlight when taking this medication". In 2014 there were no standards for these stickers, although the United States Pharmacopeia and the National Association of Boards of Pharmacy had developed standards for prescription container labels themselves.
In 2010, several companies produced warning labels for community pharmacies, as software or as stickers, and pharmacies themselves were among the producers, so different wording and pictures may be used for similar messages. The cautions on a drug company's own carton or container belong to its labeling, which goes to the FDA for review. Tell your pharmacist if small labels are hard for you to read, because the pharmacist may be able to help.
Where to read any of it again once the bag is in the trash
The drug company's labeling for an FDA-approved prescription medicine, including the Prescribing Information, the patient pages and the carton and container labeling, can be read on DailyMed, a site the National Library of Medicine, part of the National Institutes of Health, provides to the public. What you find there is the labeling the company most recently submitted to the FDA and currently has in use. It may differ from the paper in your bag and from the most recent FDA-approved labeling, the FDA may not have verified it, and the National Library of Medicine does not review it before it is posted. For the most current FDA-approved labeling of a prescription medicine, look it up on Drugs@FDA, the FDA's own database. If the online version and your paper differ on something that matters to you, ask your pharmacist which one matches the medicine you were given.
When a medicine with a Medication Guide is dispensed, the guide comes on paper, and you may ask for it electronically instead, from the pharmacy that dispenses it. Before you leave the counter, make sure you have any information the pharmacist can give you, then read it and keep it, and ask the pharmacist where and how you can get more in writing. Keep the pharmacy's phone number and opening hours with it, for questions that come up once you are home.
Who to ask when something in the papers worries you
For what a paper or a sticker means, ask your pharmacist, since a pharmacist can help you learn how to use your medicines safely. Ask what the most important information about the medicine is, when to contact the prescriber about it, and in what situations you would call 911. Tell the pharmacist every medicine you use and any change to your medicines, which includes anything you have stopped taking, so they can help you avoid medicines and other things that do not mix well with the new one (see A weekly weight medicine can change how some of your other tablets work).
If you or anyone else has taken too much of a medicine, or the wrong one, call the Poison Help line on 1-800-222-1222 right away, without waiting for signs of poisoning, and have the container nearby, because the label has important information for the call. Call 911 instead if the person is not breathing, or if they have a seizure or have passed out.
The labeling described above, from the Prescribing Information to a Medication Guide, is the labeling of FDA-approved medicines. For any other medicine, ask your pharmacist what written information comes with it. If NicoCares connected you with your prescriber, put a question about the papers that can wait, such as how a warning fits your own history, to your care team, who answer messages sent through Spruce Health's secure messaging. Those messages carry no stated reply time, so if you need the answer before you next take the medicine, call your pharmacist instead.
