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Drug labels for over-the-counter and prescription medicines provide important information on safe and proper medication use. 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.
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. These labels are short and simple and typically have six main parts. Some labels include a seventh section with a phone number to call if you have questions or comments.
The Drug Facts panel on an over-the-counter med lets you know how to take it, what’s in it, and how it might make you feel. But the way that info is written can make it tricky to understand. Here’s how to make sense of drug labels so you can avoid common, possibly dangerous mistakes.
Find this info at the top of the label on over-the-counter meds. It’s the ingredient in the medicine that treats a symptom, along with the type of medication it is, like “antihistamine” or “pain reliever”.It also tells you how much of the drug is in each dose. Check this to make sure you don’t take other drugs with the same ingredient and to understand what the product will do for you.
The Drug Facts label for the over-the-counter drug acetaminophen, known by the brand name Tylenol.
This section gives you a snapshot of the symptoms or diseases that the drug can treat. For example,a pain-reliever label might say it eases toothaches, headaches, joint pain, and menstrual cramps.Always check this part when you buy a new medication to make sure it will do what you need it to do.
This is one of the most important parts of the drug label, and it’s usually the largest. It gives you safety details about the medicine. You’ll find four things here: who shouldn’t take the drug, when you should stop using it, when to call your doctor, and side effects you might have. It can help you check if it’s not safe to take with some health conditions or other medications.
Check this part carefully. It tells you how much of the drug to take and how often to take it, called the dosage. For example, it may say to take two tablets every 4 to 6 hours. Never take more than the label says without talking to your doctor. The directions are grouped by age, so you know how much you or your child can use. You’ll also get details about the maximum amount you should take in 1 day.
Heat and humidity can sometimes damage medications, so keeping them in your bathroom or in a car when the weather’s warm may not be a good idea. This part of the label will tell you the right temperature range for storing the product. It also reminds you to make sure the package’s safety seal hasn’t been broken before you use it, which could be a sign of tampering.
These are the ingredients in a drug that don’t directly treat your symptoms. They might be preservatives, dyes, or flavorings. Always check this section if you or your child has food or dye allergies. Keep in mind that different brands of the same kind of drug may have different inactive ingredients.
Prescription drug labels are more complicated than OTC drug labels. 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. The approved prescribing information—also called professional labeling, package insert and prescribing information—is the actual prescription drug label. The prescribing information is several pages long, and it’s intended to help providers properly prescribe the medication. The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and consider as most important.
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.
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.
The full prescribing information is written for people in the medical community and elaborates on information found in the highlights section.
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.
Directions: Match the medicine with its definition .
(1) anaesthetic A. A medicine you use for helping you to cough up mucus from your lung
(2) analgesic B. A substance that prevents a poison from having bad effects
(3) antacid C. A drug or gas that is given to someone before a medical operation
(4) antibiotic D. A drug that reduces pain
(5) antidote E. A pill that you take to help you to sleep
(6) antihistamine F. A drug taken to reduce inflammation (swelling, heat, and pain)
(7) anti-inflammatory G. A drug used for preventing a woman from becoming pregnant
(8) contraceptive H. A drug used to treat an allergy
(9) emetic I. A medicine that reduces the amount of acid in your stomach
(10) expectorant J. A drug that cures illnesses and infections caused by bacteria
(11) laxative K. A medicine that helps you to make loose waste
(12) narcotic L. A drug that makes you vomit
Directions: Warning information printed or placed on the bottle as stickers may vary. Explain the following sticker’s meaning .
Directions: Find a complete English package insert of your concern and then write a pharmacy information sheet as below .
Directions: The label on the prescription bottle contains information from the doctor and the pharmacy about using the medication correctly. Use the guide below to identify the key sections .
