Drug Info: A: Acetaminophen and Salicylates (Systemic)

Some commonly used brand names are:

In the U.S.—

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

Acetaminophen and salicylate combination medicines relievepain and reduce fever. They may be used to relieve occasionalpain caused by mild inflammation or arthritis (rheumatism).The acetaminophen, aspirin, and caffeine combination also maybe used to relieve pain associated with migraineheadaches.

Neither acetaminophen nor salicylamide is as effective asaspirin for treating chronic or severe pain, or othersymptoms, caused by inflammation or arthritis. Some of thesecombination medicines do not contain any aspirin. Even thosethat do contain aspirin may not contain enough to beeffective in treating these conditions.

A few reports have suggested that acetaminophen andsalicylates used together may cause kidney damage or cancerof the kidney or urinary bladder. This may occur if largeamounts of both medicines are taken together for a very longtime. However, taking usual amounts of these combinationmedicines for a short time has not been shown to cause theseunwanted effects. Also, these effects are not likely to occurwith either acetaminophen or a salicylate used alone, even iflarge amounts have been taken for a long time. Therefore, forlong-term use, it may be best to use either acetaminophen ora salicylate, but not both, unless you are under a doctor'scare.

Before giving any of these combination medicines to achild, check the package label very carefully. Some of thesemedicines are too strong for use in children. If you arenot certain whether a specific product can be given to achild, or if you have any questions about the amount to give,check with your health care professional.

These medicines are available without a prescription.However, your doctor may have special instructions on theproper dose of these medicines for your medicalcondition.

These medicines are available in the following dosageforms:

• 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.)

If you are taking this medicine without a prescription,carefully read and follow any precautions on the label. Foracetaminophen and salicylate combinations, the following shouldbe considered:

Allergies—Tell your doctor if you haveever had any unusual or allergic reaction to acetaminophen,aspirin or other salicylates including methyl salicylate (oilof 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 allergicto any other substances, such as foods, preservatives, ordyes.

Pregnancy—

• For acetaminophen: Studies on birth defects have notbeen done in humans. However, acetaminophen has not beenreported to cause birth defects or other problems.
• For aspirin: Studies in humans have not shown thataspirin causes birth defects. However, aspirin has been shownto cause birth defects in animals.Do not take aspirin during the last 3 months of pregnancyunless it has been ordered by your doctor. Some reportshave suggested that too much use of aspirin late in pregnancymay cause a decrease in the newborn's weight and possibledeath of the fetus or newborn infant. However, the mothers inthese reports had been taking much larger amounts of aspirinthan are usually recommended. Studies of mothers takingaspirin in the doses that are usually recommended did notshow these unwanted effects. However, there is a chance thatregular use of aspirin late in pregnancy may cause unwantedeffects on the heart or blood flow in the fetus or newborninfant. Use of aspirin during the last 2 weeks of pregnancymay cause bleeding problems in the fetus before or duringdelivery, or in the newborn infant. Also, too much use ofaspirin during the last 3 months of pregnancy may increasethe length of pregnancy, prolong labor, cause other problemsduring delivery, or cause severe bleeding in the motherbefore, during, or after delivery.
• For salicylamide: Studies on birth defects have notbeen done in humans.
• For caffeine: Studies in humans have not shown thatcaffeine causes birth defects. However, use of large amountsof caffeine by the mother during pregnancy may cause problemswith the heart rhythm of the fetus and may affect the growthof the fetus. Studies in animals have shown that caffeinecauses birth defects when given in very large doses (amountsequal to the amount of caffeine in 12 to 24 cups of coffee aday).

Breast-feeding—

• For acetaminophen and for aspirin: Acetaminophen andaspirin pass into breast milk; however, they have not beenreported to cause problems in nursing babies.
• For caffeine: Caffeine (contained in some of thesecombination medicines) passes into breast milk in smallamounts. Taking caffeine in the amounts present in thesemedicines has not been reported to cause problems in nursingbabies. However, studies have shown that babies may appearjittery and have trouble in sleeping when their mothers drinklarge amounts of caffeine-containing beverages. Therefore,breast-feeding mothers who use these medicines probablyshould limit the amount of caffeine they take in from othermedicines or from beverages.

Children—

• For acetaminophen: Acetaminophen has been tested inchildren and, in effective doses, has not been shown to causedifferent side effects or problems than it does inadults.
• For aspirin and for salicylamide: Do not give a medicine containing aspirin or salicylamideto a child with symptoms of a virus infection, especially fluor chickenpox, without first discussing its use with yourchild's doctor. This is very important because aspirinmay cause a serious illness called Reye's syndrome inchildren with fever caused by a virus infection, especiallyflu or chickenpox. Children who do not have a virus infectionmay also be more sensitive to the effects of aspirin,especially if they have a fever or have lost large amounts ofbody fluid because of vomiting, diarrhea, or sweating. Thismay increase the chance of side effects duringtreatment.
• For caffeine: There is no specific informationcomparing use of caffeine in children younger than 12 yearsof age with use in other age groups. However, caffeine is notexpected to cause different side effects or problems inchildren than it does in adults.

Older adults—Elderly people may be morelikely than younger adults to develop serious kidney problemsif they take large amounts of these combination medicines for along time. Therefore, it is best that elderly people not takethis medicine for more than 5 days in a row unless they areunder a doctor's care.

• For acetaminophen: Acetaminophen has been tested and,in effective doses, has not been shown to cause differentside effects or problems in older people than it does inyounger adults.
• For aspirin: People 60 years of age and older areespecially sensitive to the effects of aspirin. This mayincrease the chance of side effects during treatment.
• For caffeine: Many medicines have not been studiedspecifically in older people. Therefore, it may not be knownwhether they work exactly the same way they do in youngeradults or if they cause different side effects or problems inolder people. There is no specific information comparing useof caffeine in the elderly with use in other age groups.

Other medicines—Although certainmedicines should not be used together at all, in other casestwo different medicines may be used together even if aninteraction might occur. In these cases, your doctor may wantto change the dose, or other precautions may be necessary. Whenyou are taking an acetaminophen and salicylate combination, itis especially important that your health care professional knowif 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 thesemedicines together with aspirin (present in some of thesecombination medicines) may increase the chance of seriousbleeding

• Antidiabetics, oral (diabetes medicine you take bymouth)—Aspirin (present in some of these combinationmedicines) may increase the effects of the antidiabeticmedicine; a change in dose may be needed if aspirin is takenregularly

• 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 bymouth—Antacids (present in buffered forms ofacetaminophen and salicylate combination medicines) can keepthese other medicines from working properly if the medicinesare taken too closely together

• Methotrexate (e.g., Mexate)—Taking aspirin (presentin some of these combination medicines) together withmethotrexate may increase the chance of serious sideeffects

• Probenecid (e.g., Benemid)—Aspirin (present in someof these combination medicines) can keep probenecid fromworking properly for treating gout

• Sulfinpyrazone (e.g., Anturane)—Aspirin (present insome of these combination medicines) can keep sulfinpyrazonefrom working properly for treating gout; also, taking aspirintogether with sulfinpyrazone may increase the chance ofbleeding

• Urinary alkalizers (medicine that makes the urine lessacid, such as acetazolamide [e.g., Diamox], calcium- and/ormagnesium-containing antacids, dichlorphenamide [e.g.,Daranide], methazolamide [e.g., Neptazane], potassium orsodium citrate and/or citric acid, sodium bicarbonate [bakingsoda])—These medicines may make aspirin (present insome of these combination medicines) less effective bycausing it to be removed from the body more quickly

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

• Anemia or
• Stomach ulcer or other stomach problems—Aspirin(present in some of these combination medicines) may makethese conditions worse

• Gout—Aspirin (present in some of these combinationmedicines) can make this condition worse and can also lessenthe effects of some medicines used to treat gout

• Heart disease—Caffeine (present in some of thesecombination medicines) can make your condition worse

• Hemophilia or other bleeding problems—Aspirin(present in some of these combination medicines) increasesthe chance of serious bleeding

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

Unless otherwise directed by your doctor:

• Do not take more of this medicine than directed on thepackage label. Taking too much acetaminophen may causeliver damage or lead to other medical problems because ofan overdose. Also, taking too much aspirin can causestomach problems or lead to other medical problems becauseof an overdose.
• Children up to 12 years of age should not take thismedicine more often than five times a day.

Check with your doctor before taking one of thesecombination medicines to treat severe or chronic inflammationor arthritis (rheumatism) . These combination medicinesmay not relieve the severe pain, redness, swelling, orstiffness caused by these conditions unless very largeamounts are taken for a long time. It is best not to take acetaminophen and salicylatecombination medicines in large amounts for a long timeunless you are under a doctor's care.

If a combination medicine containing aspirin has a strongvinegar-like odor, do not use it. This odor means themedicine is breaking down. If you have any questions aboutthis, 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 thelabel. The following information includes only theaverage 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), orpackets of oral powders that you take depends on the totalamount of acetaminophen and salicylate (aspirin and/orsalicylamide) in one capsule, tablet, or packet of oralpowder. Also, the number of doses you take each day and thetime allowed between doses depend on the strength of themedicine.

• 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 2capsules or tablets every three, four, or six hours,depending on the strength of the product. Do not takeany of these combination medicines for more than tendays, unless otherwise directed by your doctor.
    • Children—Use and dose must be determined byyour doctor.
  • For migraine headaches:
    • Adults and teenagers—The usual dose is 2tablets (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 nottake for relief of migraine headache for more than twodays, unless otherwise directed by your doctor.
    • Children—Use and dose must be determined byyour doctor.
• For oral (powder) dosage form:
  • For pain, fever, or mild arthritis symptoms:
    • Adults and teenagers—This medicine is verystrong. Each packet of powder contains 260 mg ofacetaminophen and 520 mg of aspirin (a total of 780 mgof both medicines). The usual dose is one packet ofpowder every four to six hours. Do not take thismedicine for more than ten days, unless otherwisedirected by your doctor.
    • Children—The oral powder dosage form is toostrong to use in children 12 years of age oryounger.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose of thesalicylates in these combination medicines is verydangerous in young children.
• Store away from heat and direct light.
• Do not store tablets (including caplets), capsules, orpowders in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine tobreak down.
• Do not keep outdated medicine or medicine no longerneeded. Be sure that any discarded medicine is out of thereach of children.

If you will be taking this medicine for a long time, or inhigh doses, your doctor should check your progress at regularvisits. This is especially important for elderly people,who may be more likely than younger adults to develop seriouskidney 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 thepain lasts for more than 10 days (5 days for children), ifthe pain gets worse, if new symptoms occur, or if thepainful area is red or swollen. These could be signs of aserious condition that needs treatment.
• If you are taking this medicine to bring down a fever,and the fever lasts for more than 3 days or returns, ifyour fever gets worse, if new symptoms occur, or if rednessor swelling is present. These could be signs of a seriouscondition that needs treatment.
• If you are taking this medicine for a sore throat, andthe sore throat is very painful, lasts for more than 2days, or occurs together with or is followed by fever,headache, skin rash, nausea, or vomiting.

Do not take any of the combination medicines containingaspirin for 5 days before any surgery, including dentalsurgery, unless otherwise directed by your medical doctor ordentist. Taking aspirin during this time may cause bleedingproblems.

Check the label of all over-the-counter (OTC),nonprescription, and prescription medicines you nowtake. If any of them contain acetaminophen, aspirin,other salicylates such as bismuth subsalicylate (e.g., PeptoBismol) or magnesium salicylate (e.g., Nuprin BackacheCaplets), or salicylic acid (present in some shampoos andskin products), check with your health care professional. Using any ofthem together with this medicine may cause anoverdose.

Stomach problems may be more likely to occur if you drinkthree or more alcoholic beverages while you are takingaspirin. Also, liver damage may be more likely to occur ifyou drink three or more alcoholic beverages while you aretaking acetaminophen.

Taking certain other medicines together with acetaminophenand salicylates may increase the chance of unwanted effects.The risk will depend on how much of each medicine you takeevery day, and on how long you take the medicines together.If your medical doctor or dentist directs you to take thesemedicines together on a regular basis, follow his or herdirections carefully. However, do not take any of the following medicines together withany of these combination medicines for more than a few daysunless your doctor has directed you to do so and is followingyour 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 combinationmedicines can keep other medicines from working properly. Ifyou need to take a buffered form of this medicine, and youare 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 taking enoxacin(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 taking atetracycline antibiotic by mouth.
• At least 1 or 2 hours before or after taking any othermedicine by mouth.

If you are taking a laxative containing cellulose, do nottake it within 2 hours of taking this medicine. Taking thelaxative and this medicine close together may make thismedicine less effective by preventing the salicylate in itfrom being absorbed by your body.

Acetaminophen and salicylate combinations may interferewith the results of some medical tests. Before you have anymedical tests, tell the person in charge if you have takenany of these combination medicines within the past 3 or 4days. If possible, it is best to call the laboratory wherethe test will be done about 4 days ahead of time to find outwhether the medicine may be taken during the 3 or 4 daysbefore the test.

For patients with diabetes:

• Acetaminophen and salicylate combinations may causefalse results with some blood and urine glucose (sugar)tests. If you notice any change in your test results, or ifyou have any questions about this possible problem, checkwith your health care professional. This is especiallyimportant if your diabetes is not well-controlled.

For patients taking one of the products that contain caffeine:

• Caffeine may interfere with the results of a test thatuses adenosine (e.g., Adenocard) or dipyridamole (e.g.,Persantine) to help find out how well your blood is flowingthrough certain blood vessels. Therefore, you should nothave any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have taken anoverdose of this medicine, get emergency help at once.Taking an overdose of a salicylate may cause unconsciousnessor death. The first symptom of an aspirin overdose may beringing or buzzing in the ears. Other signs includeconvulsions (seizures), hearing loss, confusion, severedrowsiness or tiredness, severe excitement or nervousness,and unusually fast or deep breathing. Signs of severeacetaminophen overdose may not appear until 2 to 4 days afterthe overdose is taken, but treatment to prevent liver damageor death must be started within 24 hours or less after theoverdose is taken.

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the followingside 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 ofbreath, troubled breathing, tightness in chest, orwheezing; sudden decrease in amount of urine; swellingof eyelids, face, or lips
  
  

• Signs and symptoms of overdose
  • Agitation, anxiety, excitement, irritability,nervousness, or restlessness; any loss of hearing;bloody urine; confusion or delirium; convulsions(seizures); diarrhea (severe or continuing); dizzinessor lightheadedness; drowsiness (severe); fast or deepbreathing ; fast or irregular heartbeat (for medicinescontaining caffeine); fever; frequent urination (formedicines 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 or twitching (for medicines containingcaffeine); nausea or vomiting (continuing, sometimeswith blood); ringing or buzzing in ears (continuing);seeing flashes of “zig-zag” lights (formedicines containing caffeine) ; stomach cramps or pain(severe or continuing); swelling, pain, or tendernessin the upper abdomen or stomach area; trouble insleeping (for medicines containing caffeine);uncontrollable flapping movements of the hands,especially in elderly 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 doctor as soon as possible if any ofthe following side effects occur:

• Less common or rare
  • Bloody or black, tarry stools; bloody or cloudyurine; fever with or without chills (not present beforetreatment and not caused by the condition beingtreated); pain in lower back and/or side (severe and/orsharp); pinpoint red spots on skin; skin rash, hives,or itching; sores, ulcers, or white spots on lips or inmouth; sore throat (not present before treatment andnot caused by the condition being treated); stuffynose; swelling of face, fingers, feet, or lower legs;unusual bleeding or bruising; unusual tiredness orweakness; vomiting of blood or material that looks likecoffee grounds; weight gain; yellow eyes or skin
  
  

Other side effects may occur that usually do not needmedical attention. These side effects may go away duringtreatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effectscontinue or are bothersome:

• More common
  • Heartburn or indigestion (for medicines containingaspirin); nausea, vomiting, or stomach pain (formedicines containing aspirin)
  
  

• Less common
  • Drowsiness (for medicines containing salicylamide);trouble in sleeping, nervousness, or jitters (formedicines containing caffeine)
  
  

Some side effects may occur after you have stopped takingthese combination medicines, especially if you have takenlarge amounts of them for a long time. Check with your doctor immediately if any of theseside effects occur after you have stopped taking thesemedicines:

• Rare
  • Bloody or cloudy urine; decreased urination ;swelling of face, fingers, feet, or lower legs ; weightgain
  
  

Other side effects not listed above may also occur in somepatients. If you notice any other effects, check with yourdoctor.