Maalox Total Stomach Relief

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Subsalicylate can cause a serious and sometimes fatal condition called Reye's syndrome in children.

You should not use bismuth subsalicylate if you are allergic to it, or if you have:

• a stomach ulcer;

• a recent history of stomach or intestinal bleeding; or

• if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• fever;

• mucus in your stools;

• diabetes;

• arthritis; or

• gout.

Ask a doctor before using bismuth subsalicylate if you are pregnant.

Bismuth subsalicylate can pass into breast milk and may harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

• hearing loss or ringing in your ears;

• diarrhea lasting longer than 2 days; or

• worsened stomach symptoms.

Common side effects include:

• constipation;

• dark colored stools; or

• black or darkened tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask a doctor or pharmacist if it is safe for you to use bismuth subsalicylate if you are also using any of the following drugs:

• a blood thinner such as warfarin (Coumadin, Jantoven);

• insulin or oral diabetes medications;

• probenecid (Benemid);

• an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

• medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or

• other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

This list is not complete. Other drugs may interact with bismuth subsalicylate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to bismuth subsalicylate: compounding powder, oral suspension, oral tablet, oral tablet chewable

Nervous system

Rare (less than 0.1%): Myoclonic encephalopathy
Frequency not reported: Weakness, fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, jerky movements, mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, incontinence[Ref]

Nervous system toxicity is a common feature of bismuth toxicity. Bismuth toxicity is characterized by the insidious onset of weakness and fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, and jerky movements. Acute toxicity may result in the development of mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, and incontinence.

Myoclonic encephalopathy has occurred in patients who have ingested bismuth for several months to years, but the incidence is very rare. Recovery of patients from bismuth encephalopathy may take several months following discontinuation of use. Bismuth encephalopathy has generally been reported in patients ingesting salts other than subsalicylate.[Ref]

Other

Salicylism has been reported in patients who chronically ingest bismuth subsalicylate (the active ingredient contained in Maalox Total Relief) Common complaints include vertigo, diminished hearing, lethargy, CNS dysfunction, confusion, tinnitus, vomiting, and abdominal pain. Patients may present with respiratory alkalosis and metabolic acidosis, azotemia, and hypoprothrombinemia and platelet dysfunction. The elderly may be particularly vulnerable to the development of salicylism.[Ref]

Frequency not reported: Salicylism[Ref]

Gastrointestinal

Very common (10% or more): Black stool
Common (1% to 10%): Black tongue
Frequency not reported: Nausea, vomiting[Ref]

Some side effects of Maalox Total Relief may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.