Up & Up Bismuth - Regular Strength

In the U.S.

• Bismatrol
• Diotame
• Kaopectate
• Kapectolin
• Kola-Pectin
• Pepto Bismol

In Canada

• Bismuth Extra Strength
• Bismuth Original Formula
• Compliments Bismuth - Regular Strength
• GoodSense Bismuth - Regular Strength
• Pepto-Bismol
• Stomach Relief - Regular Formula
• Up & Up Bismuth - Regular Strength
• Up & Up Extra Strength Bismuth

Available Dosage Forms:

• Suspension
• Tablet
• Tablet, Chewable

Therapeutic Class: Antacid, Bismuth Containing

Chemical Class: Salicylate, Non-Aspirin

Bismuth subsalicylate is used to treat diarrhea in adults and teenagers. It is also used to relieve the symptoms of an upset stomach, such as heartburn, indigestion, and nausea in adults and teenagers.

This medicine is available without a prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine should not be used in children younger than 12 years of age. The fluid loss caused by diarrhea may result in a severe condition. In older children with diarrhea, medicine for diarrhea may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, children are usually more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

The bismuth in this medicine may cause severe constipation in children.

In addition, do not use this medicine to treat nausea or vomiting in children or teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting is present, check with the child's doctor immediately because this could be an early sign of Reye's syndrome.

Geriatric

The fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons with diarrhea should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, the elderly may be more sensitive to the effects of salicylates. This may increase the chance of side effects during treatment. In addition, the bismuth in this medicine may cause severe constipation in the elderly.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Digoxin
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doxycycline
• Probenecid
• Sulfinpyrazone
• Tamarind

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dysentery—This condition may get worse; a different kind of treatment may be needed

• Gout—The salicylate in this medicine may worsen the gout and make the medicines taken for gout less effective

• Hemophilia or other bleeding problems—The salicylate in this medicine may increase the chance of bleeding

• Kidney disease—There is a greater chance of side effects because the body may be unable to get rid of the bismuth subsalicylate

• Stomach ulcer—Use of this medicine may make the ulcer worse

This section provides information on the proper use of a number of products that contain bismuth subsalicylate. It may not be specific to Up & Up Bismuth - Regular Strength. Please read with care.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

For safe and effective use of this medicine:

• Follow your doctor's instructions if this medicine was prescribed.
• Follow the manufacturer's package directions if you are treating yourself.

For patients using this medicine to treat diarrhea:

• It is very important that the fluid lost by the body be replaced and that a proper diet be followed. For the first 24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, broth, and gelatin. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the diarrhea worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur:
  • Decreased urination
  • Dizziness and lightheadedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

If you are taking the oral suspension: Use the dose cup that is included to measure out the right amount of medicine. If you are unsure, contact your doctor or pharmacist.

If you are taking the oral tablets: Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

If you are taking the chewable tablets: Chew up the tablet or allow it to completely disintegrate in your mouth before swallowing it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension):
  • For diarrhea or upset stomach:
    • Adults and teenagers—The usual dose is 2 tablespoonfuls every half-hour to one hour if needed. You should not take more than 16 tablespoonfuls of the regular-strength suspension or 8 tablespoonfuls of the concentrate in twenty-four hours.
    • Children—Should not be used in children younger than 12 years of age.
• For oral dosage forms (tablets or chewable tablets):
  • For diarrhea or upset stomach:
    • Adults and teenagers—The usual dose is 2 tablets every half-hour to one hour. You should not take more than 16 tablets in twenty-four hours.
    • Children—Should not be used in children younger than 12 years of age.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking this medicine may lead to overdose. If you have any questions about this, check with your health care professional.

For diabetic patients:

• False urine sugar test results may occur if you are regularly taking large amounts of bismuth subsalicylate or other salicylates.
• Smaller doses or occasional use of bismuth subsalicylate usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
  • you are not sure how much salicylate you are taking every day.
  • you notice any change in your urine sugar test results.
  • you have any other questions about this possible problem.

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

If you are taking this medicine for diarrhea, check with your doctor:

• if your symptoms do not improve within 2 days or if they become worse.
• if you also have a high fever.

Along with its needed effects, a medicine 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:

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 this medicine.

• 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.