Contact A Lawyer
Near You

Contact us today for a complimentary consultation with a qualified attorney near you.

Understanding Drug Labeling

Understanding drug labeling is easier today than it was just a few years ago, due to a 2006 regulation by the U.S. Food and Drug Administration (FDA) requiring new labels on over-the-counter (OTC) medicines. OTC medicines are available without a prescription, and thus most of the time when an individual takes an OTC product, he or she does not have a doctor's guidance.

The Drug's Purpose, Dose, Warnings, Etc.

With a prescription medicine, a physician and/or pharmacist will confirm the patient's understanding of the drug’s labeling and instructions. The schedule for taking the medicine, its possible side effects, and any further pertinent information and warnings are explained in detail by these healthcare professionals.

Over-the-Counter Medicines

For OTC products, in contrast, consumers are a bit more "on their own" when it comes to understanding drug labeling. There are thousands of OTC products on the market in the U.S. — in fact, the FDA keeps track of 80 categories of therapeutic OTC drugs. Just a few examples of OTC products are:

  • Pain relievers
  • Cold, flu, allergy and sinus medicines
  • Headache remedies
  • Cough syrup
  • Antihistamines
  • The Plan B contraceptive
  • Diuretics
  • Laxatives
  • Sleep aids
  • Weight loss products
  • Diabetes management products
  • Muscle relaxants
  • Smoking cessation products

Required Information on Drug Labels

Nowadays, all OTC drug product labels have clear, standardized usage information and warning language, intended to increase consumers' understanding so that they can choose and use these products correctly and safely. Each label has information about the following:

  • Active ingredient(s) — These are the ingredients that give the product its therapeutic effect. The amounts of the active ingredients are also given.
  • Uses — This is a description of the disease or symptoms the product is meant to treat or prevent.
  • Warnings — The warning language may tell when the product should not be used; possible interactions or side effects; conditions that merit advice from a doctor before taking the product; when a doctor should be contacted; what pregnant or breastfeeding women should know; and that the product should be kept out of children’s reach.
  • Inactive ingredients — Substances such as flavoring or coloring
  • Purpose — The product's category or action (such as pain reliever, antihistamine, or antacid)
  • Directions — How much to take, how to take the product, how often and how long to take it, and age- or weight-specific directions
  • Other information — For instance, required information about some ingredients (such as the amount of sodium the product contains), or how to store the product properly

The Typical Medicine Cabinet

Understanding drug labeling has become much easier with the above required information, much like the revised nutrition labeling for food products that began a few years ago. Grab any American-made OTC product out of the bathroom medicine cabinet in a typical American home, and check for yourself — its labeling will include the elements described here.

If you still have questions, your local pharmacist is a great resource. You don't need an appointment, and you needn't pay an office fee — just go to the drugstore and ask the pharmacist about your concerns. He or she will be happy to assist you.

Contact a Consumer Drug Safety Recall Lawyer

More Consumer-drug-safety Resources