Peptic Relief

Bismuth subsalicylate is an antacid and anti-diarrhea medication.

Bismuth subsalicylate is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

Bismuth subsalicylate may also be used for purposes not listed in this medication guide.

Bismuth subsalicylate is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

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. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children.

You should not use bismuth subsalicylate 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.

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.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more than 8 doses in one day (24 hours).

Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed before you swallow it.

Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.

Store at room temperature away from moisture and heat. Do not freeze.

Since bismuth subsalicylate is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. Do not take more than 8 doses in one day (24 hours).

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: oral suspension, oral tablet, oral tablet chewable

Along with its needed effects, bismuth subsalicylate (the active ingredient contained in Peptic Relief) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bismuth subsalicylate:

In some patients bismuth subsalicylate may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you Stop taking bismuth subsalicylate.

• Anxiety
• any loss of hearing
• confusion
• constipation (severe)
• diarrhea (severe or continuing)
• difficulty in speaking or slurred speech
• dizziness or lightheadedness
• drowsiness (severe)
• fast or deep breathing
• headache (severe or continuing)
• increased sweating
• increased thirst
• mental depression
• muscle spasms (especially of face, neck, and back)
• muscle weakness
• nausea or vomiting (severe or continuing)
• ringing or buzzing in ears (continuing)
• stomach pain (severe or continuing)
• trembling
• uncontrollable flapping movements of the hands (especially in elderly patients) or other uncontrolled body movements
• vision problems

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