CHPA Urges America’s Consumers to Read and Follow the Label Directions on OTC Analgesic Products

Washington, D.C. (January 13, 2003)–Over-the-counter (OTC) analgesics are used by millions of Americans each year because they offer safe and effective relief for a variety of common healthcare ailments. Health professionals and the U.S. Food and Drug Administration (FDA) agree that OTC analgesic products are proven to be safe and effective in the reduction of fever and to relieve aches and pains due to headache, sprains and strains, cold, flu, toothache, menstrual cramps, and other minor complaints.

As with all medicines, there can be risks associated with not reading and closely following the label instructions when taking OTC analgesics. It is important that consumers refer to the label information each and every time any OTC product is used. In addition, consumers should pay close attention to their symptoms. If the pain or fever persists or is recurring too frequently, a doctor or pharmacist should be consulted.

It is critical for consumers to keep in mind, however, that improper use or intentional abuse of OTC products, such as taking more than is recommended or taking for a longer period of time than is recommended, may result in serious health consequences. The OTC label is the first line of defense in informing consumers how to appropriately take the product and what to do in the event that symptoms persist or adverse reactions occur.

Information contained on all OTC medicine labels includes:

  • Directions (including how much of the product to take, how to take the product and how often to take it, and how long to take the product),
  • Warnings (including when not to use the product; conditions that may require consulting a health professional before taking; possible interactions or side effects; when to discontinue use of the product; and when to contact a healthcare professional),
  • Uses (symptoms or diseases the product will treat or prevent),
  • The active ingredient and amount per unit,
  • The purpose (product action or category, such as analgesic or antacid),
  • Inactive ingredients, and
  • Other information (such as proper storage of the product).

The manufacturers that produce OTC medicines have a long history of working together with FDA to ensure that consumers are provided with the best label information possible. In addition, the OTC companies have continuing education efforts that provide consumers with materials and programs on the importance of reading and following label directions.

Contacts: Donna Edenhart and Mimi Pappas, (202) 429-9260

CHPA is the 122-year-old trade association representing U.S. manufacturers and distributors of nonprescription, over-the-counter medicines and dietary supplement products. Consumer information regarding the safe and responsible use of OTC medicines and the importance of reading product label is available at