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How to Read an Over-the-Counter Medication Label

Every over-the-counter (OTC) or prescription medication is required to have a Drug Facts Label that provides standard information required by the Food and Drug Administration. It is important to take the time to read this label completely. The information will help you select the product that is best for you or your family member’s condition. The Drug Facts Label will also tell you what the medication is used for, how to use the medication, and if a medication is right for you and your symptoms. The following list explains what information is contained in each section of the Drug Facts Label:

Active ingredient
The active ingredient produces the desired effect from the medication. This section also tells you how much medication is in each dosage unit such as tablet, capsule, or certain amount of liquid. There may be more than one active ingredient in combination products, such as those that are used to treat cough and cold symptoms.

Purpose
The purpose is what the medication will do for you. For example, it might relieve pain, lessen allergy symptoms, or reduce heartburn.

Uses
This section refers to the reason for taking this medication. There may be one or more uses listed on the label.

Warnings
This section lists safety information about the medication. It will tell you:

  • When not to use it
  • What conditions may require advice from a doctor or pharmacist before taking the product
  • Things you shouldn’t do while taking the medication
  • When to stop using or taking the medication, and when to contact a doctor
  • If you can take the product when you are pregnant or breastfeeding

It is a good idea to talk to your doctor or pharmacist before using any OTC medication. They may have specific recommendations for you.

Directions
This section contains information about how much of the medication to take, how often to take it, and how long to use the medication.

Other information
This section explains how to safely store the medication. Remember to always keep all medications out of reach of children.

Inactive ingredients
Inactive ingredients such as coloring, flavoring, preservatives, or fillers are added to the medication during manufacturing. Allergic reactions to an inactive ingredient are rare but may occur. Check “Allergic Reactions to Inactive Ingredients in Medications” for more information.

Additional information may be listed on the product or outside packaging such as:

  • Expiration date: The expiration date is the date beyond which the manufacturer cannot recommend the safety and effectiveness of the medication. Every medication should have an expiration date on the box and on the bottle itself. Do not use a medication beyond its expiration date.
  • Lot or batch code: Manufacturer information in case of a recall or to help identify the product.
  • Other details: This may include the name of the manufacturer, packer, or distributor, and the address

By Samar Nicolas, Pharm.D., Medication Safety, Quality, and Informatics Fellow – Saint Vincent Hospital/MCPHS University, Worcester, MA