The Drugs Facts label found on all over-the-counter (OTC) medicines tells you the main active ingredients, what the medicine treats, how to use it, and special warnings so you can determine whether the medicine is right for you and your problem. If you can’t find the Drug Facts label, it may be hidden behind the main label, so look for an arrow that directs you to peel back the main label. Look at the sample Drug Facts label below. All Drug Facts labels provide this information in the same order. Be sure to read the Drug Facts label carefully before purchasing and using any OTC product. If you have any questions, ask your pharmacist or doctor.
This section includes the active ingredients in each dosage unit (e.g., tablet, capsule). The active ingredient tells you the generic name(s) of the medicine(s) in the product. The active ingredients work in your body to relieve your symptoms or prevent a condition. Don't be fooled by a medicine's name—always check the active ingredients. Two medicines that have the same active ingredients should not be used at the same time, unless your doctor has instructed you to do so. For example, prescription pain medicines and OTC cold medicines may both contain acetaminophen and should not be taken at the same time.
This section tells you the category or type of medicine for each active ingredient.
This section tells you what symptoms or conditions the medicine is approved to treat.
The information in this section includes warnings for those who should not take this medicine or those who should ask a doctor before use. This section also provides other warnings such as side effects, when to stop using the medicine, and pregnancy-related warnings.
If all of the required information does not fit onto one panel, an arrow will guide you where to look for the additional information.
This section describes how much medicine to take and how often to take it. It also includes the ages of those who should not use the medicine, or when someone should call a doctor for the recommended dose.
This section provides other important information about the medicine such as, how it should be stored, if the product has a tamper resistant feature, and if the product contains certain ingredients in a specific amount (such as phenylalanine, calcium, magnesium, and sodium).
This section lists other ingredients in the medicine that are used to make the medicine but have no effect in treating or preventing your symptoms or condition. Inactive ingredients may include substances that some people may need to avoid (e.g., soy).
Some labels also provide a telephone number or website as a resource in case you have questions about taking the product.
Please note: The Drug Facts labeling requirements do not apply to dietary supplements such as vitamins and herbals, which are regulated by FDA as food products and labeled with a Supplement Facts panel.
