Which part of the prescription contains the special instructions and warnings to patients?

Consumers should always read drug labels to make sure they are taking a medication correctly and safely as well as to learn about possible side effects. Unfortunately, these labels can be challenging for the average person to understand.

If you struggle to make sense of the information on your drug labels, you are not alone.

“Several studies have shown that patients often have difficulty in reading and understanding medication labels, which may lead to medication errors such as taking the wrong medication or the wrong dose,” said Mireille Hobeika, who received her doctorate in pharmacy from the University of Saint Joseph in West Hartford, Connecticut.

Understanding drug labels is even more important for people with chronic illnesses and seniors. They have the greatest risk of medication errors or interactions because they tend to take multiple medications.

There are two kinds of drug labels: over-the counter drug labels — also called Drug Facts — and prescription drug labels, which include many pages of safety information, such as pharmacy information sheets, medication guides and prescribing information.

Before you start taking a new medication, review the drug label with your doctor and pharmacist and let them know of any health conditions you have and any medications and supplements you take.

Over-the-counter, or OTC, drugs are medications that don’t require a prescription. Manufacturers print drug labels called Drug Facts directly on OTC drug product packages.

Any product with a substance intended for diagnosis, cure, treatment, prevention or mitigation of a disease is a drug, according to the Food and Drug Administration — including products like fluoride toothpaste and antidandruff shampoo. If you are unsure whether a product is an OTC drug, check the packaging for a Drug Facts label.

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Over-the-counter products such as fluoride toothpaste include drug labels on their packaging.

Four out of five American adults commonly take OTC drugs, according to a 2018 article by Stefanie Ferreri, PharmD, BCACP, a clinical professor at the University of North Carolina Eshelman School of Pharmacy in Chapel Hill.

In 2016, the most popular OTC drugs included pain relievers, heartburn drugs such as Prilosec and Nexium, upper respiratory drugs and toothpaste, Ferreri said in her article, which was published by Pharmacy Times.

Information on OTC Drug Labels

In 1999, the FDA created a regulation to simplify and standardize the Drug Facts label. It required most OTC drugs to follow the new format and content requirements by May 2002.

These labels are short and simple and typically have six main parts, Hobeika said. Some labels include a seventh section with a phone number to call if you have questions or comments.

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The Drug Facts label for the over-the-counter drug acetaminophen, known by the brand name Tylenol, includes information about ingredients, uses, warnings and directions.

1. Active Ingredient and Purpose. This section lists the ingredient that makes the drug work. It also lists what the active ingredient does and how much of it is in each medication dose. In this example, the drug contains 500 mg of acetaminophen per caplet, and its purpose is to relieve pain and reduce fever. “It is very important to check [this information] to understand what will be the effect of the drug and to avoid taking other drugs with the same ingredients by mistake,” Hobeika said.
2. Uses. This section tells you what symptoms and conditions the drug can treat. It’s important to make sure you are using the right drug for your symptoms.
3. Warnings. This section is typically the longest section of the Drug Facts label. It tells you about any severe side effects or drug interactions that can occur and describes who should not use the drug. It tells you when to stop using the drug and when to consult your doctor and/or pharmacist.
4. Directions. This section of the label tells you when, how and how often to take the drug. Keep in mind that children may have different instructions from adults. “Do not take more than what the label says before asking your doctor,” Hobeika said. “Taking a higher dose than what it is recommended on the drug label can be dangerous.”
5. Other Information. This section tells you how to store the drug. Some drugs may be sensitive to heat or moisture.
6. Inactive Ingredients. In addition to the active ingredient that makes the drug work, medications also have ingredients such as dyes, preservatives and flavoring agents. “It is important to check this information to help avoid ingredients that may cause an allergic reaction,” Hobeika said.
7. Questions or Comments. This section includes contact information available to consumers with questions about the product. It may not exist on all Drug Facts labels.

Prescription Drug Labels

Prescription drug labels are more complicated than OTC drug labels. More than half a million Americans misinterpret prescription drug labels each year, according to Consumer Reports.

The FDA doesn’t regulate the labels from pharmacies. Warning information printed or placed on the bottle as stickers may vary depending on the pharmacy.

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Prescription labels may contain warning stickers.

For example, Consumer Reports staffers filled prescriptions for warfarin at different pharmacies and found that packaging from Target, Walgreens, CVS, Costco and Walmart included different numbers of warnings for the same prescription. Walmart didn’t include any warning on the first attempt to fill the prescription.

“Labeling can be confusing, vague, misleading, hidden in medical jargon or missing altogether,” said Rachel Brummert, a patient advocate and FDA special employee. “If prescription labeling were consistent, we could avoid many of the problems caused by inconsistent labeling.”

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Drug labeling can vary depending on the pharmacy.

Pharmacy Information Sheets

The drug label printed on prescription drug packaging doesn’t tell you all the safety information for the drug, so pharmacies will give you a pharmacy information sheet. On this sheet, look for warnings or cautions, drug uses, how to use the drug, side effects, precautions, drug interactions, overdose information and how to store the drug.

Pharmacy information sheets have basic use, warning and side effect information but can be incomplete.

However, the pharmacy information sheet may not be complete, said Dr. Michael Carome, director of Public Citizen’s Health Research Group.

“Lots of [prescription] drugs have pharmacy information sheets, and often … those information sheets have not been reviewed by the FDA,” Carome said. “And the information may not be as accurate in terms of things to watch out for.”

When Consumer Reports filled prescriptions for warfarin it found “incomplete or hard-to-read package inserts — and in four of five cases, a dangerous omission that violated an FDA regulation.”

Carome recommends finding the official FDA-approved prescribing information online on the drug manufacturer’s website or on DailyMed, a site administered by the National Institutes of Health.

Prescribing Information

According to the FDA, the approved prescribing information — also called the package insert — is the actual prescription drug label. The prescribing information is several pages long, may contain about 17 sections and it’s intended to help providers properly prescribe the medication.

Other names for this information include professional labeling, package insert and prescribing information. The FDA updates this information regularly on DailyMed.

FDA Requirements for Prescription Drug Labeling

• Is based on human data when possible
• Is accurate and informative
• Is a summary for the effective and safe use of the drug
• Does not make claims or suggest uses if evidence is lacking
• Is not false, misleading or promotional

Prescribing information can be more complicated to read, but it includes more detailed safety information than the pharmacy drug label or information sheet. Plus the FDA has reviewed it for accuracy unlike information provided to you by the pharmacy. If you have trouble interpreting prescribing information, your doctor or pharmacist might be able to help you better understand important information.

In 2006, the FDA issued a final rule that changed the format of product labels to make it easier for health care professionals.

“The label is now divided into highlights of prescribing information, contents of the full prescribing information (FPI) and the FPI,” Hobeika said. “The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and consider as most important.”

Highlights of Prescribing Information

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The Highlights of Prescribing Information for Coumadin, the brand name of warfarin, provides health care practitioners with a half-page summary of the most commonly referred to safety information.

1. Name of Drug. The very first section will tell you the name of the drug. It will show you the brand name as well as the generic name, or active ingredient, in parentheses. This section also tells you what formulation it is (injection, oral, etc.) and the year the FDA approved the drug.
2. Black Box Warning. If there is a black box warning for the drug, it will be at the top of the page. The boxed warning provides the most important safety information about the drug. In the case of Coumadin, it warns about the risk of major or fatal bleeding.
3. Recent Major Changes. Below the black box warning, you will find any recent major changes to the prescribing information and the date they were made. The FDA will add or remove warnings. If you have been taking the same medication for a while, it is a good idea to check this section periodically to see if there have been new warnings added. However, this section is not always included.
4. Indications and Usage. This section lists all of the conditions the FDA has approved the drug to treat. Sometimes health care providers can legally prescribe drugs for off-label uses, which are uses not approved by the FDA. Such uses might not be supported by data that proves safety or effectiveness, however. All information in the prescribing information is specifically for FDA-approved uses only.
5. Dosage and Administration. Here you can find information about the recommended amount of the drug and how to give it to a patient. For example, the Coumadin dose depends on tests a health care provider runs, and it is specific to the patient.
6. Dosage Forms and Strengths. All of the different doses available from the manufacturer are listed here. Providers can recommend any dose and may increase or decrease the dose over time. Coumadin starts at 1 mg and goes up to 10 mg in its pill form, and the drug for injection comes in a vial containing 5 mg of powder. Check the label on your prescription package from the pharmacy for the dose that your provider has prescribed for you.
7. Contraindications. Not all medications are safe for everyone. This section tells providers who should not take the drug.
8. Warnings and Precautions. Warnings and precautions inform doctors about serious conditions that can occur in people taking the drug. It alerts them to health problems to watch for in their patients who take the drug. For example, people taking Coumadin might suffer rare tissue death or gangrene that may lead to amputation.
9. Adverse Reactions. Look here for the most common side effects suffered by people taking the drug. Coumadin’s most common reactions are fatal and nonfatal bleeding. This section also provides contact information to report side effects to the manufacturer and the FDA.
10. Drug Interactions. Drugs listed in this section may interact with the medication, increasing or decreasing its effectiveness or causing more side effects.
11. Use in Specific Populations. The drug may affect people differently depending on characteristics such as age, gender, race, pregnancy or the presence of kidney or liver impairment. This section warns about safety or effectiveness concerns in these groups.

Full Prescribing Information

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The full prescribing information is written for people in the medical community and elaborates on information found in the highlights section.

The full prescribing information expands on the information provided in the highlights section. This part of the prescribing information is the most complicated because manufacturers write it for health care providers, scientists and researchers, not patients.

In addition to the highlights, it contains information on how the drug works, how long it lasts in the body and how the body gets rid of the drug. It will also talk about animal studies, which might provide information about whether or not the drug causes cancer or infertility.

The manufacturers also share results of clinical trials, data showing how well the drug works and its side effects from those clinical trials.

Diana Zuckerman, president of the National Center for Health Research, recommends patients consider the following questions and tips when reading clinical trial data on drug labels.

• Were patients in the study like you in terms of age, sex, race and other characteristics? Look for at least 30 patients like you in the study. It might not provide you the most relevant data if people in the study aren’t similar enough to you.
• Were patients in the study like you in terms of medical diagnosis? For example, if it’s a cancer drug, did the study involve people with your type of cancer? The same goes for drugs that treat other diseases. Data might be less relevant to you if you are not represented by patients in the study.
• Is the drug tested in people who failed at other treatments? The FDA approves some higher risk drugs for people with no other treatment options.

Medication Guides

If a drug has an FDA-approved medication guide, pharmacists are supposed to give it to patients with their prescription, but this doesn’t always happen. And not all drugs have them.

The FDA requires manufacturers to write medication guides in easy-to-understand language for patients. You can find these medication guides on the drug manufacturer’s website or on DailyMed.

The blood thinner Coumadin, also known under the generic name warfarin, has a medication guide. Similar to the Drug Facts on an OTC label, the medication guide tells patients the most important prescription drug information in simple language.

Information in a Medication Guide

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Manufacturers are required to write medication guides in language that's easy for patients to understand.

1. What is the most important information I should know about the drug? The most serious risks, side effects and symptoms you should look for are detailed here.
2. What is the drug? Here you can find the condition or symptoms the drug treats.
3. Who should not take the drug? This section describes diseases or health conditions that may worsen with use of the drug. It also addresses people who may be allergic to the drug.
4. Before taking the drug. If you have diseases or health conditions listed in this section, talk to your doctor before taking the medication.
5. How should I take the drug? This section explains the special instructions on how to take the drug. It reminds people to take the drug only as directed by their doctor.
6. What are the possible side effects of the drug? This section includes side effects information and brief explanations about each side effect. Sometimes it includes information on tests your provider may run or symptoms to watch for.
7. How should I store the drug? Information on how to store the drug is included here. Some drugs are sensitive to heat or cold and some may need refrigeration.
8. What are the ingredients in the drug? Check this section for the active and inactive ingredients. Tell your provider if you are allergic to any ingredients in the drug.

Side Effect Information

While serious side effects are rare, it's important that you seek the advice of a medical professional before making health care decisions. Learn about potential drug and device side effects.

View Side Effects

Is Side Effect Information Always Accurate?

Side effect information on drug labels usually comes from clinical trial data collected before a manufacturer sells the drug. Sometimes the label will get an update based on side effect reports the FDA receives after the drug has been on the market. This information is called postmarketing data.

“If side effects are known, they should always be included on the label, but some side effects aren’t known until years after a product goes on the market,” Zuckerman said.

“If side effects are known, they should always be included on the label, but some side effects aren’t known until years after a product goes on the market.”

Drug manufactures can face lawsuits if they know about a side effect but fail to warn consumers and doctors.

“Back when I took Levaquin in 2006, there were no black box warnings on fluoroquinolones,” said Brummert, who suffered multiple ruptured tendons after taking the antibiotic. “The first warning came in 2008 for tendon ruptures, and that black box only stated that people over 60 were at risk. Adverse reactions I have suffered that are still not included in the warnings are autonomic and central nervous system dysfunction and neurodegenerative disorders.”

Brummert said she discovered the FDA had admitted to these side effects in a hidden document obtained through a Freedom of Information Act request.

What Should You Do If You Don’t Understand a Label?

If you have tried reading a drug label and don’t understand it, don’t be afraid to ask for help. Your health care providers, such as doctors and pharmacists, are there to assist you.

“Before leaving the doctors’ office, patients should make sure they are well informed about the name of the drug and why they are taking it, the medical conditions this drug treats, how many times per day should they take it, how long will it take this drug to work, when should they stop taking it, are there any side effects that they should know about and any situations where they should not be taking the drug,” Hobeika said.

If you leave your health care provider’s office without the information you need to take your medicine safely and effectively, the pharmacy from where you pick up your medication can help. Your pharmacist can answer questions about OTC and prescription medications.

Hobeika recommends having all prescriptions filled at the same pharmacy, so the pharmacist has a record of them. She also suggests doing the following before you leave the pharmacy:

• Check the label to make sure your name is on it. If it isn’t, talk to the pharmacist.
• Check the label to make sure you can read and understand the name of the medicine, directions and colored warning stickers on the package. If the letters are too small to read, ask your pharmacist to print it in a larger type.
• Are the directions on the package the same as those you and your provider discussed? If not, tell the pharmacist.
• Ask if there are special instructions on how to store the medicine. Should it be kept in the refrigerator or a dry place?
• Ask if there is anything you shouldn’t eat or drink while taking the medicine.
• Ask if it’s safe to take the drug with other prescriptions or OTC medicines you’re taking.

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