ACETAMINOPHEN,SODIUM BICARBONATE, AND CITRIC ACID (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Bromo-Seltzer

? Not commercially available in Canada.

Category

• Analgesic-antacid

Description

Acetaminophen, sodium bicarbonate,and citric acid (a-seat-a-MIN-oh-fen,SOE-dee-um bi-KAR-boe-nate, and SI-trik AS-id) combinationis used to relieve pain occurring together with heartburn, sour stomach, oracid indigestion. The acetaminophen in this combination medicine is the painreliever. The sodium bicarbonate in this medicine is an antacid. It neutralizesstomach acid by combining with it to form a new substance that is not an acid.

This medicine is available without a prescription; however, your doctormay have special instructions on the proper dose for your medical condition.

Acetaminophen, sodium bicarbonate, and citric acid combination is availablein the following dosage form:

Oral
• Effervescent granules (U.S.)

Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For acetaminophen, sodium bicarbonate, and citric acid combination, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to acetaminophen or aspirin, or to sodium bicarbonate. Alsotell your health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Although studies on birth defects have not been donein humans, the ingredients in this combination medicine have not been reportedto cause birth defects in humans. However, you should avoid this medicineif you tend to retain (keep) body water because the sodium in it can causethe body to hold water. This can result in swelling and weight gain.

Breast-feeding?Acetaminophen passes into the breast milk in smallamounts. However, acetaminophen, sodium bicarbonate, and citric acid havenot been reported to cause problems in nursing babies.

Children?Acetaminophen has been tested in children and hasnot been shown to cause different side effects or problems than it does inadults. However, sodium bicarbonate should not be given to young children(under 6 years of age) unless ordered by their doctor. Small children withstomach problems usually cannot describe their symptoms very well. They shouldbe checked by a doctor, because they may have a condition that needs othertreatment.

Older adults?Acetaminophen has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults. However, the large amount of sodium in this combination medicinecan be harmful to some elderly people. Therefore, it is best that older peoplenot use this medicine for more than 5 days in a row, unless otherwise directedby their doctor.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingthis combination medicine, it is especially important that your health careprofessional know if you are taking any of the following:

• Alcohol?The chance of liver damage may be increased

• Ciprofloxacin (e.g., Cipro) or
• Enoxacin (e.g., Penetrex) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Lomefloxacin (e.g., Maxaquin) or
• Methenamine (e.g., Mandelamine) or
• Norfloxacin (e.g., Noroxin) or
• Ofloxacin (e.g., Floxin) or
• Tetracyclines (medicine for infection), taken by mouth?Sodiumbicarbonate can keep these medicines from working properly

• Mecamylamine (e.g., Inversine)?Sodium bicarbonate can increasethe risk of unwanted effects by causing mecamylamine to stay in your bodylonger than usual

Other medical problems?The presence of other medicalproblems may affect the use of acetaminophen, sodium bicarbonate, and citricacid combination. Make sure you tell your doctor if you have any other medicalproblems, especially:

• Alcohol abuse or
• Hepatitis or other liver disease?The chance of serious sideeffects, including liver damage, may be increased

• Appendicitis (symptoms of, such as stomach or lower abdominal pain,cramping, bloating, soreness, nausea, or vomiting)?Sodium bicarbonatecan make your condition worse; also, people who may have appendicitis needmedical attention and should not try to treat themselves

• Edema (swelling of face, fingers, feet, or lower legs caused by toomuch water in the body) or
• Heart disease or
• High blood pressure or
• Toxemia of pregnancy?The sodium in this combination medicinecan make these conditions worse

• Kidney disease?The chance of serious side effects may be increased

Proper Use of This Medicine

Make certainyour health care professional knows if you are on a low-sodium, low-sugar,or any other special diet. This medicine contains a large amount of sodium(more than 750 mg for each 325 mg of acetaminophen).

Unless otherwise directed by your doctor, do not takemore of this medicine than is recommended on the package label. Iftoo much is taken, liver damage or other serious side effects may occur.

To use this medicine:

• This medicine must be taken in the form of a liquid that is madefrom the effervescent granules. Do not swallow the granules themselves.
• To make the liquid, pour the amount of effervescent granules directedon the package into a glass. Then add 1/2 glass (4 ounces) of cool water.
• Drink all of the liquid. You may drink the liquid while it is stillfizzing or after the fizzing stops.
• Add a little more water to the glass and drink that, to make surethat you get the full amount of the medicine.

Dosing?The dose of this combination medicine willbe different for different people. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of the acetaminophen in this combination medicine. If your dose is different, do not change it unlessyour doctor tells you to do so.

• For oral dosage form (effervescent granules):
  • For pain and upset stomach:
    • Adults and teenagers?325 to 650 milligrams (mg) of acetaminophen,dissolved in water, every four hours as needed. The bottle cap can be usedto measure the dose. There are 325 mg of acetaminophen in three-fourths ofa capful.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If your doctor has directed you to take this medicineaccording to a regular schedule and you miss a dose, take it as soon as youremember. However, if it is almost time for your next dose, skip the misseddose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink,or in other damp places. Heat or moisture may cause the medicine to breakdown.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If youwill be taking this medicine for a long time (more than 10 days in a row),your doctor should check your progress at regular visits.

Check with your doctor if your pain and/or upset stomach last for morethan 10 days or if they get worse, if new symptoms occur, or if the painfularea is red or swollen. These could be signs of a serious condition that needsmedical treatment.

The sodium bicarbonate in this combination medicine can keep other medicinesfrom working properly if the 2 medicines are taken too close together. Always take this medicine:

• At least 6 hours before or 2 hours after takingciprofloxacin (e.g., Cipro) or lomefloxacin (e.g., Maxaquin).
• At least 8 hours before or 2 hours after takingenoxacin (e.g., Penetrex).
• At least 2 hours after taking itraconazole (e.g.,Sporanox).
• At least 3 hours before or after taking ketoconazole(e.g., Nizoral).
• At least 2 hours before or after taking norfloxacin(e.g., Noroxin) or ofloxacin (e.g., Floxin).
• At least 3 or 4 hours before or after takinga tetracycline antibiotic by mouth.
• At least 1 or 2 hours before or after takingany other medicine by mouth.

Check the labels of all nonprescription (over-the-counter[OTC]) and prescription medicines you now take. If any contain acetaminophen or sodium, check with your health care professional. Taking them together with this medicine may cause an overdose.

Taking certain other medicines together with acetaminophen may increasethe chance of unwanted effects. The risk will depend on how much of each medicineyou take every day, and on how long you take the medicines together. If yourmedical doctor or dentist directs you to take these medicines together ona regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with acetaminophen formore than a few days, unless your doctor has directed you to do so and isfollowing your progress:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

If you will be taking more than an occasional 1 or 2 doses of this medicine:

• Do not drink alcoholic beverages. Drinkingalcoholic beverages while you are taking acetaminophen may increase the chanceof liver damage, especially if you drink large amounts of alcoholic beveragesregularly, if you take more acetaminophen than is recommended on the packagelabel, or if you take it regularly for a long time.
• Do not also drink a lot of milk or eat a lotof milk products. To do so may increase the chance of side effects.
• To prevent side effects caused by too much sodium in the body, youmay need to limit the amount of sodium in the foods you eat. Some foods thatcontain large amounts of sodium are canned soup, canned vegetables, pickles,ketchup, green and ripe (black) olives, relish, frankfurters and other sausage-typemeats, soy sauce, and carbonated beverages. If you have any questions aboutthis, check with your health care professional.

Acetaminophen may interfere with the results of some medical tests. Beforeyou have any medical tests, tell the person in charge if you have taken acetaminophenwithin the past 3 or 4 days. If possible, it is best to call the laboratorywhere the test will be done about 4 days ahead of time, to find out whetherthis medicine may be taken during the 3 or 4 days before the test.

For diabetic patients:

• Acetaminophen may cause false results with some blood glucose (sugar)tests. If you notice any change in your test results, or if you have any questionsabout this possible problem, check with your health care professional. Thisis especially important if your diabetes is not well-controlled.

If you think that you or anyone else may have takenan overdose of this medicine, get emergency help at once, even if there areno signs of poisoning. Signs of severe acetaminophen poisoning maynot appear for 2 to 4 days after the overdose is taken, but treatment to preventliver damage or death must be started as soon as possible. Treatment startedmore than 24 hours after the overdose is taken may not be effective.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although the following side effectsoccur very rarely when 1 or 2 doses of this combination medicine is takenoccasionally, they may be more likely to occur if:

• too much medicine is taken
• the medicine is taken several times a day
• the medicine is taken for more than a few days in a row

Check with your doctorimmediately if any of the following side effects occur:

Rare

Yellow eyes or skin

Symptoms of overdose

Diarrhea; increased sweating; loss of appetite; nausea or vomiting; stomach cramps or pain; swelling, pain, or tenderness in the upper abdomen or stomach area

Also, checkwith your doctor as soon as possible if any of the following side effectsoccur:

Less common or rare

Bloody or black, tarry stools; bloodyor cloudy urine, frequent urge to urinate, or sudden decrease in amount ofurine; fever with or without chills (not presentbefore treatment and not caused by the condition being treated); headache (continuing); increased bloodpressure; mood or mental changes; muscle pain or twitching; nervousness or restlessness; pain (severe and/or sharp) in lower back and/orside; skin rash, hives, or itching; slow breathing; sores, ulcers, or whitespots on lips or in mouth; sore throat (not presentbefore treatment and not caused by the condition being treated); swelling of face, fingers, ankles, feet, or lower legs; unpleasant taste; unusual bleeding orbruising; unusual tiredness or weakness; weight gain

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

Less common

Increased thirst

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.