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.
Due to the potential for serious adverse events from product confusion, the maker
of Maalox brand products has agreed to:
Advice for Consumers
- Change the name of Maalox Total Relief to one that will not include the
name “Maalox” and revise the graphics and information displayed on the front
of the product container to help distinguish the active ingredients and uses of
this product from the traditional Maalox antacids.
- An educational program that includes outreach to healthcare professionals and
consumers to inform them about the different products sold under the Maalox
brand, including how to select the appropriate Maalox brand product.
- Active safety monitoring and reporting of adverse events associated with the
use of Maalox brand products.
To help avoid potentially serious health risks associated with Maalox product mix-
ups, the FDA recommends that consumers:
- Check with a healthcare professional or pharmacist if they are not sure
what Maalox product is right for them.
- Carefully look at the labels of all Maalox products to make sure the right
product is being purchased for the right condition.
- Read the active ingredients, uses and warnings in the “Drug Facts” box prior to
purchasing any Maalox product.
- Report any side effects from the use of Maalox products to the FDA
MedWatch program, using the information at the bottom of this page.
The company expects to begin selling the renamed product in September 2010.
Until that time, healthcare professionals and consumers should be aware of the
Additional Information for Healthcare Professionals
- Maalox Total Relief and the traditional Maalox products are both liquid
medications available without a prescription (OTC), but are NOT
interchangeable. These products are intended to treat different medical
- Maalox Total Relief is not appropriate for individuals who want to use an
antacid, especially if they have a history of gastrointestinal ulcer disease or a
- 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 adverse effects such as
bleeding. Bismuth subsalicylate has a warning statement stating that it should
not be used in people who have or have a history of gastrointestinal ulcers or
a bleeding disorder.
- The traditional Maalox liquid 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. Both are OTC products and are used for the relief of acid
indigestion, heartburn, sour stomach, upset stomach, and pressure and
bloating commonly referred to as gas.
- Maalox Total Relief should not be confused with traditional Maalox liquid
- When recommending an OTC product such as Maalox, refer to the product by
its full product name (for example, Maalox Total Relief, Maalox Advanced Regular
Strength, or Maalox Advanced Maximum Strength) or use the active ingredient
- Ensure that patients know the product name and understand the uses of the
product prior to purchase.
- Report adverse events or medication errors involving Maalox products, such as
using the wrong product because of confusing names, to the FDA MedWatch
program. By phone at 1-800-332-1088; By fax at 1-800-FDA-0178; by
computer at medWatch Online