FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.
Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.
The Drug Safety Communication contains additional information for consumers and healthcare professionals, as well as product label photos.