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U.S. Department of Health and Human Services

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Questions and Answers on Proposed Rule for Labeling Changes to Over-the-Counter Pain Relievers

12/2006

1.  What is the Food and Drug Administration (FDA) announcing today?

The Food and Drug Administration (FDA) today proposed to amend the labeling regulations to add important safety information for over-the-counter (OTC) Internal Analgesic, Antipyretic and Antirheumatic (IAAA) drug products.  These products are used to treat pain, fever, headaches and muscle aches. 

New warnings are proposed for labeling of nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, regarding the potential for stomach bleeding.  New warnings are proposed for labeling of acetaminophen about potential liver damage and when to consult a doctor.  

 2.  What labeling changes is FDA proposing?

For Products Containing NSAIDs

  • To require that the name of the NSAID ingredient and the term “NSAID” be prominently identified on the product’s principal display panel (PDP) of the immediate container and the outer carton (if applicable).
  • To require new warnings which would highlight the potential for stomach bleeding in people who use certain other medications or are otherwise at high risk for stomach problems.  

For Products Containing Acetaminophen

  • To require that the ingredient acetaminophen be prominently identified on the product’s principal display panel (PDP) of the immediate container, and the outer carton (if applicable).
  • To require new warnings which would highlight the potential for liver toxicity and to warn consumers against using more than the recommended dose of acetaminophen; using more than one product (over-the-counter or prescription) containing with acetaminophen, and taking acetaminophen with moderate amounts of alcohol.

3.  What products would this proposed rule affect?

The new labeling would be required for all OTC drug products that contain only an IAAA ingredient or acetaminophen, as well as products that contain an IAAA ingredient or acetaminophen with other ingredients, such as cold symptom relievers.  This proposed rule is applicable only to OTC drug products and not to prescription products that IAAA ingredients or acetaminophen.  Consumers may also be taking IAAA ingredients or acetaminophen in their prescription medications, so it is important that they know the contents of both their prescription and OTC medications.   

4.  What other topics is FDA asking for comments about?

FDA is continuing to collect information to make decisions about other aspects of IAAA and acetaminophen use.  For acetaminophen products, FDA would like to better understand whether there are any people, other than those discussed in the proposed labeling, who should not take the recommended dose of acetaminophen.  FDA would also like information about other measures, such as limiting the number of tablets in a package.

5.  Are IAAA products and acetaminophen products safe to use?

IAAA and acetaminophen drug products have been available for many years without a prescription. These products are safe and effective when properly used by consumers. The FDA believes that consumers need to know that these products can cause serious side effects when used improperly. FDA urges people to read the labels of all the OTC medicines they take to know how to take them properly.

For more information, please see FDA news release (12/19/2006).