Safety Alerts & Recalls

What does this mean?

To help avoid potentially serious health risks associated with Maalox product mix-ups, the FDA recommends that consumers:

1) Check with a healthcare professional or pharmacist if they are not sure what Maalox product is right for them.

2) Carefully look at the labels of all Maalox products to make sure the right product is being purchased for the right condition.

3) Read the active ingredients, uses, and warnings in the "Drug Facts" box prior to purchasing any Maalox product

4) Report any side effects from the use of Maalox products to the FDA MedWatch program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Product Confusion with Maalox Total Relief and Maalox Liquid Products

The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used MAALOX TOTAL RELIEF, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional MAALOX LIQUID ANTACID products.

MAALOX TOTAL RELIEF and the traditional MAALOX LIQUID ANTACID products are both liquid medications available over-the-counter (OTC) without a prescription, but are NOT interchangeable. These products are intended to treat different medical conditions.

MAALOX TOTAL RELIEF is not appropriate for individuals who want to use an antacid, especially if they have a history of a bleeding disorder or ulcers of the stomach or intestines. MAALOX TOTAL RELIEF contains the active ingredient bismuth subsalicylate and is used to treat diarrhea, upset stomach associated with nausea, heartburn, and gas due to overindulgence in food (overeating). Bismuth subsalicylate is chemically related to aspirin and may cause similar side effects such as bleeding.

The traditional MAALOX LIQUID ANTACID products including MAALOX ADVANCED REGULAR STRENGTH and MAALOX ADVANCED MAXIMUM STRENGTH are well-recognized antacid drug products that contain aluminum hydroxide, magnesium hydroxide, and simethicone. The traditional MAALOX LIQUID ANTACID products are used for the relief of acid indigestion, heartburn, sour stomach, upset stomach, and pressure and bloating commonly referred to as gas.

Due to the potential for serious adverse events from product confusion, the maker of Maalox brand products has taken several steps to promote the safe use of Maalox products, including changing the name of MAALOX TOTAL RELIEF to one that will not include the name "Maalox" and improving the graphics and information displayed on the product container to help distinguish the active ingredients and uses of this product from the traditional MAALOX LIQUID ANTACID products.

For more information and photos of the Maalox product labels, please visit: more information here and

more information here

Source: FDA
Publication Date: 2010-02-18
Last Updated: 2010-02-20

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