ACETAMINOPHENAND SALICYLATES (Systemic)

Some commonly used brand names are:

In the U.S.?

• Excedrin Extra-Strength Caplets ¹
• Excedrin Extra-Strength Tablets ¹
• Excedrin Migraine ¹
• Gelpirin ²
• Goody's Fast Pain Relief ¹
• Goody's Headache Powders ¹
• Rid-A-Pain Compound ⁴
• Saleto ³
• Supac ²
• Vanquish Caplets ²

Category

• Analgesic?Acetaminophen, Aspirin, and Caffeine; Acetaminophen, Aspirin, and Caffeine, Buffered; Acetaminophen, Aspirin, Salicylamide, and Caffeine; Acetaminophen, Salicylamide, and Caffeine
• Antipyretic?Acetaminophen, Aspirin, and Caffeine; Acetaminophen, Aspirin, and Caffeine,Buffered; Acetaminophen, Aspirin, Salicylamide,and Caffeine; Acetaminophen, Salicylamide,and Caffeine
• Antimigraine?Acetaminophen, Aspirin, and Caffeine

Description

Acetaminophen and salicylate combination medicinesrelieve pain and reduce fever. They may be used to relieve occasional paincaused by mild inflammation or arthritis (rheumatism). The acetaminophen,aspirin, and caffeine combination also may be used to relieve pain associatedwith migraine headaches.

Neither acetaminophen nor salicylamide is as effective as aspirin for treatingchronic or severe pain, or other symptoms, caused by inflammation or arthritis.Some of these combination medicines do not contain any aspirin. Even thosethat do contain aspirin may not contain enough to be effective in treatingthese conditions.

A few reports have suggested that acetaminophen and salicylates used togethermay cause kidney damage or cancer of the kidney or urinary bladder. This mayoccur if large amounts of both medicines are taken together for a very longtime. However, taking usual amounts of these combination medicines for a shorttime has not been shown to cause these unwanted effects. Also, these effectsare not likely to occur with either acetaminophen or a salicylate used alone,even if large amounts have been taken for a long time. Therefore, for long-termuse, it may be best to use either acetaminophen or a salicylate, but not both,unless you are under a doctor's care.

Before giving any of these combination medicines toa child, check the package label very carefully. Some of these medicines aretoo strong for use in children. If you are not certain whether a specificproduct can be given to a child, or if you have any questions about the amountto give, check with your health care professional.

These medicines are available without a prescription. However, your doctormay have special instructions on the proper dose of these medicines for yourmedical condition.

These medicines are available in the following dosage forms:

Oral
• Acetaminophen, Aspirin, and Caffeine
  • Oral powders (U.S.)
  • Tablets (U.S.)
• Acetaminophen, Aspirin, and Caffeine, Buffered
  • Tablets (U.S.)
• Acetaminophen, Aspirin, Salicylamide, and Caffeine
  • Tablets (U.S.)
• Acetaminophen, Salicylamide, and Caffeine
  • Capsules (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 and salicylate combinations, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to acetaminophen, aspirin or other salicylates includingmethyl salicylate (oil of wintergreen), or to any of the following medicines:

• 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)

Also tell your health care professional if you are allergic to any othersubstances, such as foods, preservatives, or dyes.

Pregnancy?

• For acetaminophen: Studies on birth defectshave not been done in humans. However, acetaminophen has not been reportedto cause birth defects or other problems.
• For aspirin: Studies in humans have notshown that aspirin causes birth defects. However, aspirin has been shown tocause birth defects in animals.
  Do not take aspirin during the last 3 months of pregnancyunless it has been ordered by your doctor. Some reports have suggestedthat too much use of aspirin late in pregnancy may cause a decrease in thenewborn's weight and possible death of the fetus or newborn infant. However,the mothers in these reports had been taking much larger amounts of aspirinthan are usually recommended. Studies of mothers taking aspirin in the dosesthat are usually recommended did not show these unwanted effects. However,there is a chance that regular use of aspirin late in pregnancy may causeunwanted effects on the heart or blood flow in the fetus or newborn infant.
  Use of aspirin during the last 2 weeks of pregnancy may cause bleedingproblems in the fetus before or during delivery, or in the newborn infant.Also, too much use of aspirin during the last 3 months of pregnancy may increasethe length of pregnancy, prolong labor, cause other problems during delivery,or cause severe bleeding in the mother before, during, or after delivery.
• For salicylamide: Studies on birth defectshave not been done in humans.
• For caffeine: Studies in humans have notshown that caffeine causes birth defects. However, use of large amounts ofcaffeine by the mother during pregnancy may cause problems with the heartrhythm of the fetus and may affect the growth of the fetus. Studies in animalshave shown that caffeine causes birth defects when given in very large doses(amounts equal to the amount of caffeine in 12 to 24 cups of coffee a day).

Breast-feeding?

• For acetaminophen and for aspirin: Acetaminophenand aspirin pass into breast milk; however, they have not been reported tocause problems in nursing babies.
• For caffeine: Caffeine (contained in someof these combination medicines) passes into breast milk in small amounts.Taking caffeine in the amounts present in these medicines has not been reportedto cause problems in nursing babies. However, studies have shown that babiesmay appear jittery and have trouble in sleeping when their mothers drink largeamounts of caffeine-containing beverages. Therefore, breast-feeding motherswho use these medicines probably should limit the amount of caffeine theytake in from other medicines or from beverages.

Children?

• For acetaminophen: Acetaminophen has beentested in children and, in effective doses, has not been shown to cause differentside effects or problems than it does in adults.
• For aspirin and for salicylamide: Do not give a medicine containing aspirin or salicylamide toa child with symptoms of a virus infection, especially flu or chickenpox,without first discussing its use with your child's doctor. This isvery important because aspirin may cause a serious illness called Reye's syndromein children with fever caused by a virus infection, especially flu or chickenpox.Children who do not have a virus infection may also be more sensitive to theeffects of aspirin, especially if they have a fever or have lost large amountsof body fluid because of vomiting, diarrhea, or sweating. This may increasethe chance of side effects during treatment.
• For caffeine: There is no specific informationcomparing use of caffeine in children younger than 12 years of age with usein other age groups. However, caffeine is not expected to cause differentside effects or problems in children than it does in adults.

Older adults?Elderly people may be more likely thanyounger adults to develop serious kidney problems if they take large amountsof these combination medicines for a long time. Therefore, it is best thatelderly people not take this medicine for more than 5 days in a row unlessthey are under a doctor's care.

• For acetaminophen: Acetaminophen has beentested and, in effective doses, has not been shown to cause different sideeffects or problems in older people than it does in younger adults.
• For aspirin: People 60 years of age andolder are especially sensitive to the effects of aspirin. This may increasethe chance of side effects during treatment.
• For caffeine: Many medicines have notbeen studied specifically in older people. Therefore, it may not be knownwhether they work exactly the same way they do in younger adults or if theycause different side effects or problems in older people. There is no specificinformation comparing use of caffeine in the elderly with use in other agegroups.

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 takingan acetaminophen and salicylate combination, it is especially important thatyour health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Carbenicillin by injection (e.g., Geopen) or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Heparin or
• Inflammation or pain medicine, except narcotics, or
• Pentoxifylline (e.g., Trental) or
• Plicamycin (e.g., Mithracin) or
• Ticarcillin (e.g., Ticar) or
• Valproic acid (e.g., Depakene)?Taking these medicines togetherwith aspirin (present in some of these combination medicines) may increasethe chance of serious bleeding

• Antidiabetics, oral (diabetes medicine you take by mouth)?Aspirin(present in some of these combination medicines) may increase the effectsof the antidiabetic medicine; a change in dose may be needed if aspirin istaken regularly

• 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
• Norfloxacin (e.g., Noroxin) or
• Ofloxacin (e.g., Floxin) or
• Tetracyclines (medicine for infection), taken by mouth?Antacids(present in buffered forms of acetaminophen and salicylate combination medicines)can keep these other medicines from working properly if the medicines aretaken too closely together

• Methotrexate (e.g., Mexate)?Taking aspirin (present in someof these combination medicines) together with methotrexate may increase thechance of serious side effects

• Probenecid (e.g., Benemid)?Aspirin (present in some of thesecombination medicines) can keep probenecid from working properly for treatinggout

• Sulfinpyrazone (e.g., Anturane)?Aspirin (present in some ofthese combination medicines) can keep sulfinpyrazone from working properlyfor treating gout; also, taking aspirin together with sulfinpyrazone may increasethe chance of bleeding

• Urinary alkalizers (medicine that makes the urine less acid, suchas acetazolamide [e.g., Diamox], calcium- and/or magnesium-containing antacids,dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane], potassiumor sodium citrate and/or citric acid, sodium bicarbonate [baking soda])?Thesemedicines may make aspirin (present in some of these combination medicines)less effective by causing it to be removed from the body more quickly

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

• Alcohol abuse or
• Asthma, allergies, and nasal polyps (history of) or
• Hepatitis or other liver disease or
• Kidney disease?The chance of serious side effects may be increased

• Anemia or
• Stomach ulcer or other stomach problems?Aspirin (present insome of these combination medicines) may make these conditions worse

• Gout?Aspirin (present in some of these combination medicines)can make this condition worse and can also lessen the effects of some medicinesused to treat gout

• Heart disease?Caffeine (present in some of these combinationmedicines) can make your condition worse

• Hemophilia or other bleeding problems?Aspirin (present in someof these combination medicines) increases the chance of serious bleeding

Proper Use of This Medicine

Take this medicine with food or a full glass (8 ounces) of water tolessen the chance of stomach upset.

Unless otherwise directed by your doctor:

• Do not take more of this medicine than directedon the package label. Taking too much acetaminophen may cause liverdamage or lead to other medical problems because of an overdose. Also, takingtoo much aspirin can cause stomach problems or lead to other medical problemsbecause of an overdose.
• Children up to 12 years of age should not takethis medicine more often than five times a day.

Check with your doctor before taking one of these combinationmedicines to treat severe or chronic inflammation or arthritis (rheumatism). These combination medicines may not relieve the severe pain, redness,swelling, or stiffness caused by these conditions unless very large amountsare taken for a long time. It is best not to take acetaminophenand salicylate combination medicines in large amounts for a long timeunless you are under a doctor's care.

If a combination medicine containing aspirin has astrong vinegar-like odor, do not use it. This odor means the medicineis breaking down. If you have any questions about this, check with your pharmacist.

Dosing?The dose of acetaminophen and salicylate combinationmedicines will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of these combination medicines. If your dose is different, do not change it unlessyour doctor tells you to do so.

The number of capsules, tablets (including caplets), or packets of oralpowders that you take depends on the total amount of acetaminophen and salicylate(aspirin and/or salicylamide) in one capsule, tablet, or packet of oral powder.Also, the number of doses you take each day and the time allowed between dosesdepend on the strength of the medicine.

• For oral (capsules or tablets [including caplets]) dosage forms:
  • For pain, fever, or mild arthritis symptoms:
    • Adults and teenagers?The usual dose is 1 or 2 capsules or tabletsevery three, four, or six hours, depending on the strength of the product.Do not take any of these combination medicines for more than ten days, unlessotherwise directed by your doctor.
    • Children?Use and dose must be determined by your doctor.
  • For migraine headaches:
    • Adults and teenagers?The usual dose is 2 tablets (250 mg acetaminophen,and 250 mg of aspirin, and 65 mg of caffeine in combination) every six hoursas necessary for relief from migraine headaches. Do not take for relief ofmigraine headache for more than two days, unless otherwise directed by yourdoctor.
    • Children?Use and dose must be determined by your doctor.
• For oral (powder) dosage form:
  • For pain, fever, or mild arthritis symptoms:
    • Adults and teenagers?This medicine is very strong. Each packetof powder contains 260 mg of acetaminophen and 520 mg of aspirin (a totalof 780 mg of both medicines). The usual dose is one packet of powder everyfour to six hours. Do not take this medicine for more than ten days, unlessotherwise directed by your doctor.
    • Children?The oral powder dosage form is too strong to use inchildren 12 years of age or younger.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose of the salicylates inthese combination medicines is very dangerous in young children.
• Store away from heat and direct light.
• Do not store tablets (including caplets), capsules, or powders inthe bathroom, near the kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down.
• 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, or in high doses, your doctor should check your progress at regular visits. This is especiallyimportant for elderly people, who may be more likely than younger adults todevelop serious kidney problems if they take large amounts of this medicinefor a long time.

Check with your doctor:

• If you are taking this medicine to relieve pain and the pain lastsfor more than 10 days (5 days for children), if the pain gets worse, if newsymptoms occur, or if the painful area is red or swollen. These could be signsof a serious condition that needs treatment.
• If you are taking this medicine to bring down a fever, and the feverlasts for more than 3 days or returns, if your fever gets worse, if new symptomsoccur, or if redness or swelling is present. These could be signs of a seriouscondition that needs treatment.
• If you are taking this medicine for a sore throat, and the sore throatis very painful, lasts for more than 2 days, or occurs together with or isfollowed by fever, headache, skin rash, nausea, or vomiting.

Do not take any of the combination medicines containing aspirin for 5 daysbefore any surgery, including dental surgery, unless otherwise directed byyour medical doctor or dentist. Taking aspirin during this time may causebleeding problems.

Check the label of all over-the-counter (OTC), nonprescription,and prescription medicines you now take. If any of them contain acetaminophen,aspirin, other salicylates such as bismuth subsalicylate (e.g., Pepto Bismol)or magnesium salicylate (e.g., Nuprin Backache Caplets), or salicylic acid(present in some shampoos and skin products), check withyour health care professional. Using any of them together with this medicinemay cause an overdose.

Stomach problems may be more likely to occur if you drink three or morealcoholic beverages while you are taking aspirin. Also, liver damage may bemore likely to occur if you drink three or more alcoholic beverages whileyou are taking acetaminophen.

Taking certain other medicines together with acetaminophen and salicylatesmay increase the chance of unwanted effects. The risk will depend on how muchof each medicine you take every day, and on how long you take the medicinestogether. If your medical doctor or dentist directs you to take these medicinestogether on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together withany of these combination medicines for more than a few days unless your doctorhas directed you to do so and is following your progress:

• 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)

The antacid present in buffered forms of these combination medicines cankeep other medicines from working properly. If you need to take a bufferedform of this medicine, and you are also taking one of the following medicines, be sure to take the buffered acetaminophen and salicylatecombination 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.

If you are taking a laxative containing cellulose, do not take it within2 hours of taking this medicine. Taking the laxative and this medicine closetogether may make this medicine less effective by preventing the salicylatein it from being absorbed by your body.

Acetaminophen and salicylate combinations may interfere with the resultsof some medical tests. Before you have any medical tests, tell the personin charge if you have taken any of these combination medicines within thepast 3 or 4 days. If possible, it is best to call the laboratory where thetest will be done about 4 days ahead of time to find out whether the medicinemay be taken during the 3 or 4 days before the test.

For patients with diabetes:

• Acetaminophen and salicylate combinations may cause false resultswith some blood and urine glucose (sugar) tests. If you notice any changein your test results, or if you have any questions about this possible problem,check with your health care professional. This is especially important ifyour diabetes is not well-controlled.

For patients taking one of the products that contain caffeine:

• Caffeine may interfere with the results of a test that uses adenosine(e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out howwell your blood is flowing through certain blood vessels. Therefore, you shouldnot have any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have takenan overdose of this medicine, get emergency help at once. Taking anoverdose of a salicylate may cause unconsciousness or death. The first symptomof an aspirin overdose may be ringing or buzzing in the ears. Other signsinclude convulsions (seizures), hearing loss, confusion, severe drowsinessor tiredness, severe excitement or nervousness, and unusually fast or deepbreathing. Signs of severe acetaminophen overdose may not appear until 2 to4 days after the overdose is taken, but treatment to prevent liver damageor death must be started within 24 hours or less after the overdose is taken.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

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

Less common or rare

Coughing; difficulty in swallowing; dizziness, lightheadedness, or feeling faint (severe); flushing, redness, or other change in skin color; shortness of breath, troubled breathing, tightness in chest,or wheezing; sudden decrease in amount of urine; swelling of eyelids, face, or lips

Signs and symptoms of overdose

Agitation, anxiety, excitement, irritability, nervousness, orrestlessness; any loss of hearing; bloody urine; confusion or delirium; convulsions (seizures); diarrhea (severeor continuing); dizziness or lightheadedness; drowsiness (severe); fast or deep breathing; fast or irregular heartbeat (for medicines containingcaffeine); fever; frequenturination (for medicines containing caffeine); hallucinations(seeing, hearing, or feeling things that are not there); headache (severe or continuing); increased sensitivityto touch or pain (for medicines containing caffeine); increased sweating; increased thirst; loss of appetite; muscle trembling ortwitching (for medicines containing caffeine); nauseaor vomiting (continuing, sometimes with blood); ringing or buzzing in ears (continuing); seeing flashesof ?zig-zag? lights (for medicines containing caffeine); stomach cramps or pain (severe or continuing); swelling, pain, or tenderness in the upper abdomen or stomach area; trouble in sleeping (for medicines containing caffeine); uncontrollable flapping movements of the hands, especially inelderly patients; unexplained fever; vision problems

Signs of overdose in children

Changes in behavior; drowsiness or tiredness(severe); fast or deep breathing

Also, check with your doctoras soon as possible if any of the following side effects occur:

Less common or rare

Bloody or black, tarry stools; bloodyor cloudy urine; fever with or without chills (notpresent before treatment and not caused by the condition being treated); pain in lower back and/or side (severe and/or sharp); pinpoint red spots on skin; skin rash,hives, or itching; sores, ulcers, or white spotson lips or in mouth; sore throat (not present beforetreatment and not caused by the condition being treated); stuffy nose; swelling of face, fingers, feet, orlower legs; unusual bleeding or bruising; unusual tiredness or weakness; vomitingof blood or material that looks like coffee grounds; weight gain; yellow eyes or skin

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

More common

Heartburn or indigestion (for medicines containing aspirin); nausea, vomiting, or stomach pain (for medicines containing aspirin)

Less common

Drowsiness (for medicines containing salicylamide); trouble in sleeping, nervousness, or jitters (for medicines containingcaffeine)

Some side effects may occur after you have stopped taking thesecombination medicines, especially if you have taken large amounts of themfor a long time. Check with your doctor immediatelyif any of these side effects occur after you have stopped taking these medicines:

Rare

Bloody or cloudy urine; decreased urination; swelling of face, fingers, feet, or lower legs; weight gain

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