[9-30-2025] The Food and Drug Administration is advising consumers not to purchase or use Me Vale Madre, a product promoted and sold for migraine and stress pain on various websites, including ebay.com, and possibly in some retail stores.

FDA laboratory analysis confirmed that Me Vale Madre contains acetaminophen and diclofenac not listed on the product label.

Acetaminophen is a medicine used to reduce pain and fever that is found in many prescription and over-the-counter (OTC) drug products. Use of the product Me Vale Madre poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash and blisters.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief and body building and are often represented as being all natural. Consumers should exercise caution before purchasing these products.

FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.

For more information: