Label Changes Proposed for Over-the-Counter Drugs

Over-the-counter products which contain acetaminophen, aspirin, or NSAIDs (nonsteroidal anti-inflammatory drugs) need label changes to ensure their safe use and help consumers make more informed decisions, according to the U.S. Food and Drug Administration (FDA). Such products are classified as Internal Analgesic, Anti-pyretic, and Anti-rheumatic (IAAA) drugs. The labeling changes proposed by the FDA include the following:

New warnings on labels of products containing acetaminophen would highlight the potential for liver toxicity, especially when taking high doses of acetaminophen, when taking multiple products which contain acetaminophen, and when taken with moderate amounts of alcohol. The ingredient acetaminophen would also be prominently identified on both the display panel of the immediate container and the outer carton.

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New warnings on labels for products containing NSAIDs would highlight the potential for stomach bleeding in persons who are 60 years old and older, in persons with a prior history of ulcers or bleeding, in persons who take a blood thinner, when taking more than one product containing an NSAID, when taken with moderate amounts of alcohol, and when taking for a longer time than directed. The name of the NSAID ingredient would also be prominently identified on both the display panel of the immediate container and the outer carton.

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The Arthritis Foundation, in a statement which followed the proposed changes, recommends that people taking any pain reliever carefully read labels. Doses up to the maximum allowable dose for acetaminophen (4 grams daily) are usually well-tolerated but complications can occur if the maximum dose is exceeded. The Arthritis Foundation also feels that while the proposed changes will help inform patients, the proposal "should not change the way physicians approach these medications."

The new labeling changes would apply to all over-the-counter drugs containing a single IAAA ingredient and products containing IAAA ingredients in combination with other ingredients (e.g. cold medicines). It is important for people who take prescription medications which contain IAAA ingredients to be aware of the content of the over-the-counter medications they purchase and use.

More Related Resources:

• Review Prescription Drug Labels
• Use Caution With Over-the-Counter Pain Relievers
• Should Alcohol Be Avoided Completely By Arthritis Patients?

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