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USP DI Vol. II - SALICYLATES (Systemic)

SALICYLATES (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Acuprin 81 1
  • Amigesic 8
  • Anacin Caplets 2
  • Anacin Maximum Strength 2
  • Anacin Tablets 2
  • Anaflex 750 8
  • Arthritis Pain Ascriptin 3
  • Arthritis Pain Formula 3
  • Arthritis Strength Bufferin 3
  • Arthropan 5
  • Aspergum 1
  • Aspirin Regimen Bayer Adult Low Dose 1
  • Aspirin Regimen Bayer Regular Strength Caplets 1
  • Aspir-Low 1
  • Aspirtab 1
  • Aspirtab-Max 1
  • Backache Caplets 7
  • Bayer Children's Aspirin 1
  • Bayer Select Maximum Strength Backache Pain ReliefFormula 7
  • Bufferin Caplets 3
  • Bufferin Tablets 3
  • Buffex 3
  • Buffinol 3
  • Buffinol Extra 3
  • Cama Arthritis Pain Reliever 3
  • CMT 6
  • Cope 4
  • Disalcid 8
  • Doan's Regular Strength Tablets 7
  • Easprin 1
  • Ecotrin Caplets 1
  • Ecotrin Tablets 1
  • Empirin 1
  • Extended-release Bayer 8-Hour 1
  • Extra Strength Bayer Arthritis Pain Formula Caplets 1
  • Extra Strength Bayer Aspirin Caplets 1
  • Extra Strength Bayer Aspirin Tablets 1
  • Extra Strength Bayer Plus Caplets 3
  • Gensan 2
  • Genuine Bayer Aspirin Caplets 1
  • Genuine Bayer Aspirin Tablets 1
  • Halfprin 1
  • Healthprin Adult Low Strength 1
  • Healthprin Full Strength 1
  • Healthprin Half-Dose 1
  • Magan 7
  • Magnaprin 3
  • Marthritic 8
  • Maximum Strength Arthritis Foundation Safety CoatedAspirin 1
  • Maximum Strength Ascriptin 3
  • Maximum Strength Doan's Analgesic Caplets 7
  • Mobidin 7
  • Mono-Gesic 8
  • Norwich Aspirin 1
  • P-A-C Revised Formula 2
  • Regular Strength Ascriptin 3
  • Salflex 8
  • Salsitab 8
  • Sloprin 1
  • St. Joseph Adult Chewable Aspirin 1
  • Tricosal 6
  • Trilisate 6
  • ZORprin 1

In Canada?

  • Anacin 2
  • Anacin Extra Strength 2
  • Antidol 2
  • Apo-Asa 1
  • Apo-ASEN 1
  • Arco Pain Tablet 2
  • Arthrisin 1
  • Artria S.R 1
  • Aspergum 1
  • Aspirin Caplets 1
  • Aspirin Children's Tablets 1
  • Aspirin, Coated 1
  • Aspirin Plus Stomach Guard Extra Strength 3
  • Aspirin Plus Stomach Guard Regular Strength 3
  • Aspirin Tablets 1
  • Astone 2
  • Astrin 1
  • Bufferin Caplets 3
  • Bufferin Extra Strength Caplets 3
  • Calmine 2
  • C2 2
  • C2 Buffered 4
  • Coryphen 1
  • Disalcid 8
  • Doan's Backache Pills 7
  • Dodd's Extra Strength 9
  • Dodd's Pills 9
  • Dolomine 2
  • Entrophen Caplets 1
  • Entrophen Extra Strength 1
  • Entrophen 15 Maximum Strength Tablets 1
  • Entrophen 10 Super Strength Caplets 1
  • Entrophen Tablets 1
  • Gin Pain Pills 9
  • Headache Tablet 1
  • Herbopyrine 2
  • Instantine 2
  • Kalmex 2
  • Nervine 2
  • Novasen 1
  • Novasen Sp.C 1
  • Pain Aid 2
  • PMS-ASA 1
  • Sero-Gesic 7
  • 217 Strong 2
  • 217 2
  • Tri-Buffered ASA 3
  • Trilisate 6

Other commonly used names are:

  • acetylsalicylic acid
  • ASA #
  • choline magnesium trisalicylate
  • salicylsalicylic acid

Note:

For quick reference, the following salicylates are numbered to matchthe corresponding brand names.

This information applies to the following medicines:
1.Aspirin # (AS-pir-in)??
2.Aspirin and Caffeine (AS-pir-in and KAF-een)?
3.BufferedAspirin # **?
4.Buffered Aspirin and Caffeine #
5.Choline Salicylate (KOE-leen sa-LI-si-late)?
6.Choline and Magnesium Salicylates (KOE-leen and mag-NEE-zhum sa-LI-si-lates)?
7.Magnesium Salicylate (mag-NEE-zhum sa-LI-si-late)
8.Salsalate (SAL-sa-late)?
9.Sodium Salicylate (SOE-dee-um sa-LI-si-late)?
? Not commercially available in Canada
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

Aspirin is a brand name in Canada; acetylsalicylic acid is the generic name.ASA, a commonly used designation for aspirin (or acetylsalicylic acid) inboth the U.S. and Canada, is the term used in Canadian product labeling.

** Some of the buffered aspirinproducts may be identified on the label as Aspirin (ASA), Alumina, and Magnesiaor as Aspirin, Alumina, and Magnesium Oxide.


Category

  • Analgesic?Aspirin; Aspirin and Caffeine; Aspirin and Caffeine, Buffered; Aspirin,Buffered; Choline and Magnesium Salicylates; Choline Salicylate; Magnesium Salicylate; Salsalate; Sodium Salicylate
  • Anti-inflammatory, nonsteroidal?Aspirin; Aspirin and Caffeine; Aspirin and Caffeine, Buffered; Aspirin, Buffered; Choline and MagnesiumSalicylates; Choline Salicylate; Magnesium Salicylate; Salsalate; Sodium Salicylate
  • Antipyretic?Aspirin; Aspirin and Caffeine; Aspirin and Caffeine, Buffered; Aspirin,Buffered; Choline and Magnesium Salicylates; Choline Salicylate; Magnesium Salicylate; Salsalate; Sodium Salicylate
  • Antirheumatic, nonsteroidal anti-inflammatory?Aspirin; Aspirin andCaffeine; Aspirin and Caffeine, Buffered; Aspirin, Buffered; Choline and Magnesium Salicylates; Choline Salicylate; Magnesium Salicylate; Salsalate; Sodium Salicylate
  • Antithrombotic?Aspirin; Aspirin andCaffeine; Aspirin and Caffeine, Buffered; Aspirin, Buffered
  • Myocardial infarction prophylactic?Aspirin; Aspirin and Caffeine; Aspirin and Caffeine, Buffered; Aspirin, Buffered
  • Myocardial reinfarctionprophylactic?Aspirin; Aspirin and Caffeine; Aspirin and Caffeine,Buffered; Aspirin, Buffered
  • Platelet aggregation inhibitor?Aspirin; Aspirin and Caffeine; Aspirin and Caffeine, Buffered; Aspirin, Buffered

Description

Salicylates are used to relieve pain and reduce fever. Mostsalicylates are also used to relieve some symptoms caused by arthritis (rheumatism),such as swelling, stiffness, and joint pain. However, they do not cure arthritisand will help you only as long as you continue to take them.

Aspirin may also be used to lessen the chance of heart attack, stroke,or other problems that may occur when a blood vessel is blocked by blood clots.Aspirin helps prevent dangerous blood clots from forming. However, this effectof aspirin may increase the chance of serious bleeding in some people. Therefore,aspirin should be used for this purpose only when your doctor decides, afterstudying your medical condition and history, that the danger of blood clotsis greater than the risk of bleeding. Do not take aspirinto prevent blood clots or a heart attack unless it has been ordered by yourdoctor.

Salicylates may also be used for other conditions as determined by yourdoctor.

The caffeine present in some of these products may provide additional reliefof headache pain or faster pain relief.

Some salicylates are available only with your medical doctor's or dentist'sprescription. Others are available without a prescription; however, your medicaldoctor or dentist may have special instructions on the proper dose of thesemedicines for your medical condition.

These medicines are available in the following dosage forms:

    Oral
  • Aspirin
    • Tablets (U.S. and Canada)
    • Chewable tablets (U.S. and Canada)
    • Chewing gum tablets (U.S. and Canada)
    • Delayed-release (enteric-coated) tablets (U.S. and Canada)
    • Extended-release tablets (U.S. and Canada)
  • Aspirin and Caffeine
    • Capsules (Canada)
    • Tablets (U.S. and Canada)
  • Buffered Aspirin
    • Tablets (U.S. and Canada)
  • Buffered Aspirin and Caffeine
    • Tablets (U.S. and Canada)
  • Choline Salicylate
    • Oral solution (U.S.)
  • Choline and Magnesium Salicylates
    • Oral solution (U.S.)
    • Tablets (U.S. and Canada)
  • Magnesium Salicylate
    • Tablets (U.S. and Canada)
  • Salsalate
    • Capsules (U.S.)
    • Tablets (U.S. and Canada)
  • Sodium Salicylate
    • Tablets (Canada)
    • Delayed-release (enteric-coated) tablets (U.S.)
    Rectal
  • Aspirin
    • Suppositories (U.S. and Canada)


Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For salicylates, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to aspirin or other salicylates, including methyl 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)
  • Oxyphenbutazone (e.g., Tandearil)
  • Phenylbutazone (e.g., Butazolidin)
  • Piroxicam (e.g., Feldene)
  • Sulindac (e.g., Clinoril)
  • Suprofen (e.g., Suprol)
  • Tenoxicam (e.g., Mobiflex)
  • Tiaprofenic acid (e.g., Surgam)
  • Tolmetin (e.g., Tolectin)
  • Zomepirac (e.g., Zomax)

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

Diet?Make certain your health care professionalknows if you are on a low-sodium diet. Regular use of large amounts of sodiumsalicylate (as for arthritis) can add a large amount of sodium to your diet.Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mgof sodium in each 650-mg tablet.

Pregnancy?Salicylates have not been shown to cause birth defectsin humans. Studies on birth defects in humans have been done with aspirinbut not with other salicylates. However, salicylates caused birth defectsin animal studies.

Some reports have suggested that too much use of aspirin late in pregnancymay cause a decrease in the newborn's weight and possible death of the fetusor newborn infant. However, the mothers in these reports had been taking muchlarger amounts of aspirin than are usually recommended. Studies of motherstaking aspirin in the doses that are usually recommended did not show theseunwanted effects. However, there is a chance that regular use of salicylateslate in pregnancy may cause unwanted effects on the heart or blood flow inthe fetus or in the newborn infant.

Use of salicylates, especially aspirin, during the last 2 weeks of pregnancymay cause bleeding problems in the fetus before or during delivery or in thenewborn infant. Also, too much use of salicylates during the last 3 monthsof pregnancy may increase the length of pregnancy, prolong labor, cause otherproblems during delivery, or cause severe bleeding in the mother before, during,or after delivery. Do not take aspirin during the last3 months of pregnancy unless it has been ordered by your doctor.

Studies in humans have not shown that caffeine (present in some aspirinproducts) causes birth defects. However, studies in animals have shown thatcaffeine causes birth defects when given in very large doses (amounts equalto those present in 12 to 24 cups of coffee a day).

Breast-feeding?Salicylates pass into the breast milk. Althoughsalicylates have not been reported to cause problems in nursing babies, itis possible that problems may occur if large amounts are taken regularly,as for arthritis (rheumatism).

Caffeine passes into the breast milk in small amounts.

Children?Do not give aspirin or othersalicylates to a child or a teenager with a fever or other symptoms of a virusinfection, especially flu or chickenpox, without first discussing its usewith your child's doctor. This is very important because salicylatesmay cause a serious illness called Reye's syndrome in children and teenagerswith fever caused by a virus infection, especially flu or chickenpox.

Some children may need to take aspirin or another salicylate regularly(as for arthritis). However, your child's doctor may want to stop the medicinefor a while if a fever or other symptoms of a virus infection occur. Discussthis with your child's doctor, so that you will know ahead of time what todo if your child gets sick.

Children who do not have a virus infection may also be more sensitive tothe effects of salicylates, especially if they have a fever or have lost largeamounts of body fluid because of vomiting, diarrhea, or sweating. This mayincrease the chance of side effects during treatment.

Older adults?Elderly people are especially sensitive to the effectsof salicylates. This may increase the chance of side effects during treatment.

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 takinga salicylate, it is especially important that your health care professionalknow 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 a salicylate, especially aspirin, may increase the chance of bleeding
  • Antidiabetics, oral (diabetes medicine you take by mouth)?Salicylatesmay increase the effects of the antidiabetic medicine; a change in dose maybe needed if a salicylate is taken 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?Bufferedaspirin, choline and magnesium salicylates, and magnesium salicylate may keepthese medicines from working properly if taken too close to them
  • Methotrexate (e.g., Mexate) or
  • Vancomycin (e.g., Vancocin)?The chance of serious side effectsmay be increased
  • Probenecid (e.g., Benemid)?Salicylates can keep probenecidfrom working properly for treating gout
  • Sulfinpyrazone (e.g., Anturane)?Salicylates can keep sulfinpyrazonefrom working properly for treating gout; also, taking a salicylate, especiallyaspirin, with sulfinpyrazone may increase the 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 the salicylate less effective by causing it to be removedfrom the body more quickly

Other medical problems?The presence of other medicalproblems may affect the use of salicylates. Make sure you tell your doctorif you have any other medical problems, especially:

  • Anemia or
  • Overactive thyroid or
  • Stomach ulcer or other stomach problems?Salicylates may makeyour condition worse
  • Asthma, allergies, and nasal polyps (history of) or
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
  • High blood pressure (hypertension) or
  • Kidney disease or
  • Liver disease?The chance of side effects may be increased.
  • Gout?Salicylates can make this condition worse and can alsolessen the effects of some medicines used to treat gout
  • Heart disease?The chance of some side effects may be increased.Also, the caffeine present in some aspirin products can make some kinds ofheart disease worse
  • Hemophilia or other bleeding problems?The chance of bleedingmay be increased, especially with aspirin

Proper Use of This Medicine

Take this medicine after meals or with food (except for enteric-coatedcapsules or tablets and aspirin suppositories) to lessen stomach irritation.

Take tablet or capsule forms of this medicine witha full glass (8 ounces) of water. Also, do not lie down for about 15to 30 minutes after swallowing the medicine. This helps to prevent irritationthat may lead to trouble in swallowing.

For patients taking aspirin (including buffered aspirinand/or products containing caffeine):

  • Do not use any product that contains aspirinif it has a strong, vinegar-like odor. This odor means the medicineis breaking down. If you have any questions about this, check with your healthcare professional.
  • If you are to take any medicine that contains aspirin within 7 daysafter having your tonsils removed, a tooth pulled, or other dental or mouthsurgery, be sure to swallow the aspirin whole. Do not chew aspirin duringthis time.
  • Do not place any medicine that contains aspirin directly on a toothor gum surface. This may cause a burn.
  • There are several different forms of aspirin or buffered aspirintablets. If you are using:
    • chewable aspirin tablets, they may bechewed, dissolved in liquid, crushed, or swallowed whole.
    • delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them upbefore taking.
    • extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some maybe broken up (but must not be crushed) before swallowing if you cannot swallowthem whole. Others should not be broken up and must be swallowed whole.

To use aspirin suppositories:

  • If the suppository is too soft to insert, chill it in the refrigeratorfor 30 minutes or run cold water over it before removing the foil wrapper.
  • To insert the suppository: First remove the foil wrapper and moistenthe suppository with cold water. Lie down on your side and use your fingerto push the suppository well up into the rectum.

To take choline and magnesium salicylates (e.g., Trilisate)oral solution:

  • The liquid may be mixed with fruit juice just before taking.
  • Drink a full glass (8 ounces) of water after taking the medicine.

To take enteric-coated sodium salicylate tablets:

  • The tablets must be swallowed whole. Do not crush them or break themup before taking.

Unless otherwise directed by your medical doctor or dentist:

  • Do not take more of this medicine than recommended on the label,to lessen the chance of side effects.
  • Children up to 12 years of age should not take this medicine morethan 5 times a day.

When used for arthritis (rheumatism), this medicinemust be taken regularly as ordered by your doctor in order for it to helpyou. Up to 2 to 3 weeks or longer may pass before you feel the fulleffects of this medicine.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of solution that youtake depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, andthe length of time you take the medicine depend on whether you are takinga long-acting or a short-acting form of the medicine and the medical problemfor which you are taking the salicylate.

    For aspirin
  • For short-acting tablet, chewable tablet, anddelayed-release (enteric-coated) tablet oral dosage forms:
    • For pain or fever:
      • Adults and teenagers?325 to 500 milligrams (mg) every threeor four hours, 650 mg every four to six hours, or 1000 mg every six hoursas needed.
      • Children up to 2 years of age?Dose must be determined by yourdoctor.
      • Children 2 to 4 years of age?160 mg every four hours as needed.
      • Children 4 to 6 years of age?240 mg every four hours as needed.
      • Children 6 to 9 years of age?320 to 325 mg every four hoursas needed.
      • Children 9 to 11 years of age?320 to 400 mg every four hoursas needed.
      • Children 11 to 12 years of age?320 to 480 mg every four hoursas needed.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg a day, dividedinto several smaller doses.
      • Children?A total of 80 to 100 mg per kilogram (kg) (32 to 40mg per pound) of body weight a day, divided into several smaller doses.
    • For preventing a heart attack, stroke, or other problems caused byblood clots:
      • Adults?Most people will take 81, 162.5, or 325 mg a day or325 mg every other day. Some people taking aspirin to prevent a stroke mayneed as much as 1000 mg a day.
      • Children?Use and dose must be determined by your doctor.
  • For chewing gum tablet dosage form:
    • For pain:
      • Adults and teenagers?2 tablets every four hours as needed.
      • Children up to 3 years of age?Dose must be determined by yourdoctor.
      • Children 3 to 6 years of age?1 tablet (227 mg) up to threetimes a day.
      • Children 6 to 12 years of age?1 or 2 tablets (227 mg each)up to four times a day.
  • For long-acting oral dosage forms (extended-releasetablets):
    • For pain:
      • Adults and teenagers?1 or 2 tablets twice a day.
      • Children?The long-acting aspirin tablets are too strong foruse in children.
    • For arthritis:
      • Adults and teenagers?1 or 2 tablets twice a day, at first.Your doctor will then adjust your dose as needed.
      • Children?The long-acting aspirin tablets are too strong foruse in children.
  • For rectal dosage form (suppositories):
    • For pain or fever:
      • Adults and teenagers?325 to 650 mg every four hours as needed.
      • Children up to 2 years of age?Dose must be determined by yourdoctor.
      • Children 2 to 4 years of age?160 mg every four hours as needed.
      • Children 4 to 6 years of age?240 mg every four hours as needed.
      • Children 6 to 9 years of age?325 mg every four hours as needed.
      • Children 9 to 11 years of age?325 to 400 mg every four hoursas needed.
      • Children 11 to 12 years of age?325 to 480 mg every four hoursas needed.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg a day, dividedinto several smaller doses.
      • Children?A total of 80 to 100 mg per kilogram (kg) (32 to 40mg per pound) of body weight a day, divided into several smaller doses.
    For aspirin and caffeine
  • For oral capsule dosage form:
    • For pain or fever:
      • Adults and teenagers?325 to 500 milligrams (mg) of aspirinevery three or four hours, 650 mg of aspirin every four to six hours, or 1000mg of aspirin every six hours as needed.
      • Children up to 6 years of age?Aspirin and caffeine capsulesare too strong for use in children up to 6 years of age.
      • Children 6 to 9 years of age?325 mg every four hours as needed.
      • Children 9 to 12 years of age?325 to 400 mg every four hoursas needed.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg of aspirina day, divided into several smaller doses.
      • Children?A total of 80 to 100 mg per kilogram (kg) (32 to 40mg per pound) of body weight a day, divided into several smaller doses.
    • For preventing a heart attack, stroke, or other problems caused byblood clots:
      • Adults?325 mg a day or every other day. People who take smallerdoses of aspirin will have to use a different product. Some people takingaspirin to prevent a stroke may need as much as 1000 mg a day.
      • Children?Use and dose must be determined by your doctor.
  • For oral tablet dosage form:
    • For pain or fever:
      • Adults and teenagers?325 to 500 mg of aspirin every three orfour hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirinevery six hours as needed.
      • Children up to 9 years of age?Aspirin and caffeine tabletsare too strong for use in children up to 9 years of age.
      • Children 9 to 12 years of age?325 to 400 mg every four hoursas needed.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg of aspirina day, divided into several smaller doses.
      • Children?A total of 80 to 100 mg per kg (32 to 40 mg per pound)of body weight a day, divided into several smaller doses.
    • For preventing a heart attack, stroke, or other problems caused byblood clots:
      • Adults?325 mg a day or every other day. People who take smallerdoses of aspirin will have to use a different product. Some people takingaspirin to prevent a stroke may need as much as 1000 mg a day.
      • Children?Use and dose must be determined by your doctor.
    For buffered aspirin
  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers?325 to 500 milligrams (mg) of aspirinevery three or four hours, 650 mg of aspirin every four to six hours, or 1000mg of aspirin every six hours as needed.
      • Children up to 2 years of age?Dose must be determined by yourdoctor.
      • Children 2 to 4 years of age?One-half of a 325-mg tablet everyfour hours as needed.
      • Children 4 to 6 years of age?Three-fourths of a 325-mg tabletevery four hours as needed.
      • Children 6 to 9 years of age?One 325-mg tablet every four hoursas needed.
      • Children 9 to 11 years of age?One or one and one-fourth 325-mgtablets every four hours as needed.
      • Children 11 to 12 years of age?One or one and one-half 325-mgtablets every four hours as needed.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg of aspirina day, divided into several smaller doses.
      • Children?A total of 80 to 100 mg per kilogram (kg) (32 to 40mg per pound) of body weight a day, divided into several smaller doses.
    • For preventing a heart attack, stroke, or other problems caused byblood clots:
      • Adults?325 mg a day or every other day. People who take smallerdoses of aspirin will have to use a different product. Some people takingaspirin to prevent a stroke may need as much as 1000 mg a day.
      • Children?Use and dose must be determined by your doctor.
    For buffered aspirin and caffeine
  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers?325 or 421 milligrams (mg) of aspirinevery three or four hours, 650 mg of aspirin every four to six hours, or 842mg of aspirin every six hours as needed.
      • Children up to 2 years of age?Dose must be determined by yourdoctor.
      • Children 2 to 4 years of age?One-half of a 325-mg tablet everyfour hours as needed.
      • Children 4 to 6 years of age?Three-fourths of a 325-mg tabletevery four hours as needed.
      • Children 6 to 9 years of age?One 325-mg or 421-mg tablet everyfour hours as needed.
      • Children 9 to 11 years of age?One or one and one-fourth 325-mgtablets every four hours as needed.
      • Children 11 to 12 years of age?One or one and one-half 325-mgtablets, or one 421-mg tablet, every four hours as needed.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg of aspirina day, divided into several smaller doses.
      • Children?A total of 80 to 100 mg per kilogram (kg) (32 to 40mg per pound) of body weight a day, divided into several smaller doses.
    • For preventing a heart attack, stroke, or other problems caused byblood clots:
      • Adults?162.5 or 325 mg (one-half or one 325-mg tablet) a dayor 325 mg every other day. People who need smaller doses of aspirin will haveto use a different product. Some people taking aspirin to prevent a strokemay need as much as 1000 mg a day.
      • Children?Use and dose must be determined by your doctor.
    For choline salicylate
  • For oral dosage form (oral solution):
    • For pain or fever:
      • Adults and teenagers?One-half or three-fourths of a teaspoonfulevery three hours, one-half or one teaspoonful every four hours, or one orone and one-half teaspoonfuls every six hours as needed.
      • Children up to 2 years of age?Dose must be determined by yourdoctor.
      • Children 2 to 4 years of age?1.25 milliliters (mL) (one-fourthof a teaspoonful) every four hours as needed. This amount should be measuredby a special dropper or measuring spoon.
      • Children 4 to 6 years of age?1.66 mL every four hours as needed.This amount should be measured by a special dropper or measuring spoon.
      • Children 6 to 11 years of age?2.5 mL (one-half of a teaspoonful)every four hours as needed. This amount should be measured by a special measuringspoon.
      • Children 11 to 12 years of age?2.5 to 3.75 mL (one-half tothree-fourths of a teaspoonful) every four hours as needed. This amount shouldbe measured by a special measuring spoon.
    • For arthritis:
      • Adults?A total of five and one-half to eight teaspoonfuls aday, divided into several smaller doses.
      • Children?A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to0.28 mL per pound) of body weight a day, divided into several smaller doses.
    For choline and magnesium salicylates
  • For oral dosage forms (oral solutionor tablets):
    • For pain or fever:
      • Adults and teenagers?A total of 2000 to 3000 milligrams (mg)a day, divided into two or three doses.
      • Children weighing up to 37 kilograms (kg) (about 89 pounds)?Atotal of 50 mg per kg (20 mg per pound) of body weight a day, divided intotwo doses.
      • Children weighing more than 37 kg (90 pounds or more)?2200mg a day, divided into two doses.
    • For inflammation or arthritis:
      • Adults and teenagers?A total of 3000 mg a day, divided intotwo or three doses, to start. Your doctor will then adjust your dose as needed.
      • Children weighing up to 37 kg (about 89 pounds)?A total of50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.
      • Children weighing more than 37 kg (90 pounds or more)?2200mg a day, divided into two doses.
    For magnesium salicylate
  • For oral dosage form (tablets):
    • For pain:
      • Adults and teenagers?2 regular-strength tablets every fourhours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets everyeight hours, up to a maximum of 8 tablets a day.
      • Children?Dose must be determined by your doctor.
    For salsalate
  • For oral dosage forms (capsules or tablets):
    • For arthritis:
      • Adults and teenagers?500 to 1000 milligrams (mg) two or threetimes a day, to start. Your doctor will then adjust your dose as needed.
      • Children?Dose must be determined by your doctor.
    For sodium salicylate
  • For oral dosage forms (tablets or delayed-release[enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers?325 or 650 milligrams (mg) every fourhours as needed.
      • Children up to 6 years of age?This medicine is too strong foruse in children younger than 6 years of age.
      • Children 6 years of age and older?325 mg every four hours asneeded.
    • For arthritis:
      • Adults and teenagers?A total of 3600 to 5400 mg a day, dividedinto several smaller doses.
      • Children?A total of 80 to 100 mg per kilogram (kg) (32 to 40mg per pound) of body weight a day, divided into several smaller doses.

Missed dose?If your medical doctor or dentist has ordered youto take this medicine according to a regular schedule and you miss a dose,take it as soon as you remember. However, if it is almost time for your nextdose, skip the missed dose and go back to your regular dosing schedule. Donot double doses.

Storage?To store this medicine:

  • Keep out of the reach of children. Overdose is very dangerous inyoung children.
  • Store away from heat and direct light.
  • Do not store tablets or capsules in the bathroom, near the kitchensink, or in other damp places. Heat or moisture may cause the medicine tobreak down.
  • Keep liquid forms of this medicine from freezing.
  • Store aspirin suppositories in a cool place. It is usually best tokeep them in the refrigerator, but keep them from freezing.
  • 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

Check the labels of all nonprescription (over-the-counter [OTC])and prescription medicines you now take. If any contain aspirin or other salicylates(including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skinmedicine that contains salicylic acid or any other salicylate), check withyour health care professional. Taking or using them together with thismedicine may cause an overdose.

If you will be taking salicylates for a long time (more than 5 days ina row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.

Serious side effects can occur during treatment with this medicine. Sometimesserious side effects can occur without any warning. However, possible warningsigns often occur, including swelling of the face, fingers, feet, and/or lowerlegs; severe stomach pain, black, tarry stools, and/or vomiting of blood ormaterial that looks like coffee grounds; unusual weight gain; and/or skinrash. Also, signs of serious heart problems could occur such as chest pain,tightness in chest, fast or irregular heartbeat, or unusual flushing or warmthof skin. Stop taking this medicine and check with yourdoctor immediately if you notice any of these warning signs.

Check with your medical doctor or dentist:

  • If you are taking this medicine to relieve pain and the pain lastsfor more than 10 days (5 days for children) or if the pain gets worse, ifnew symptoms occur, or if redness or swelling is present. These could be signsof a serious condition that needs medical or dental treatment.
  • If you are taking this medicine to bring down a fever, and the feverlasts for more than 3 days or returns, if the 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.
  • If you are taking this medicine regularly, as for arthritis (rheumatism),and you notice a ringing or buzzing in your ears or severe or continuing headaches.These are often the first signs that too much salicylate is being taken. Yourdoctor may want to change the amount of medicine you are taking every day.

For patients taking aspirin to lessen the chance ofheart attack, stroke, or other problems caused by blood clots:

  • Take only the amount of aspirin ordered by yourdoctor. If you need a medicine to relieve pain, a fever, or arthritis,your doctor may not want you to take extra aspirin. It is a good idea to discussthis with your doctor, so that you will know ahead of time what medicine totake.
  • Do not stop taking this medicine for any reasonwithout first checking with the doctor who directed you to take it.

Taking certain other medicines together with a salicylate 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 yourdoctor directs you to take these medicines together on a regular basis, followhis or her directions carefully. However, do not takeany of the following medicines together with a salicylate for more than afew days, unless your doctor has directed you to do so and is following yourprogress:

  • Acetaminophen (e.g., Tylenol)
  • 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)

For diabetic patients:

  • False urine sugar test results may occur if you are regularly takinglarge amounts of salicylates, such as:
    • Aspirin: 8 or more 325-mg (5-grain), or4 or more 500-mg or 650-mg (10-grain), or 3 or more 800-mg (or higher strength),doses a day.
    • Buffered aspirin or
    • Sodium salicylate: 8 or more 325-mg (5-grain),or 4 or more 500-mg or 650-mg (10-grain), doses a day.
    • Choline salicylate: 4 or more teaspoonfuls(each teaspoonful containing 870 mg) a day.
    • Choline and magnesium salicylates: 5 ormore 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more1000-mg tablets, a day.
    • Magnesium salicylate: 7 or more regular-strength,or 4 or more extra-strength, tablets a day.
    • Salsalate: 4 or more 500-mg doses, or3 or more 750-mg doses, a day.
  • Smaller doses or occasional use of salicylates usually will not affecturine sugar tests. However, check with your health care professional (especiallyif 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.

Do not take aspirin for 5 days before any surgery, including dental surgery,unless otherwise directed by your medical doctor or dentist. Taking aspirinduring this time may cause bleeding problems.

For patients taking buffered aspirin, choline andmagnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):

  • Buffered aspirin, choline and magnesium salicylates, or magnesiumsalicylate can keep many other medicines, especially some medicines used totreat infections, from working properly. This problem can be prevented bynot taking the 2 medicines too close together. Ask your health care professionalhow long you should wait between taking a medicine for infection and takingbuffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylateat least 2 hours before or after you take the laxative. Taking these medicinestoo close together may lessen the effects of the salicylate.

For patients taking this medicine by mouth:

  • Stomach problems may be more likely to occur if you drink alcoholicbeverages while being treated with this medicine, especially if you are takingit in high doses or for a long time. Check with your doctor if you have anyquestions about this.

For patients using aspirin suppositories:

  • Aspirin suppositories may cause irritation of the rectum. Check withyour doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Beforeyou have any medical tests, tell the doctor in charge if you have taken anyof these medicines within the past week. If possible, it is best to checkwith the doctor first, to find out whether the medicine may be taken duringthe week before the test.

For patients taking one of the products that contain caffeine:

  • Caffeine may interfere with the result 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 at least 8 to 12 hours before the test.

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


Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. When this medicine is used for short periodsof time at low doses, side effects usually are rare. Although not all of thefollowing side effects may occur, if they do occur they may need medical attention.

    Get emergency help immediately if any of the following side effects occur:

      Any loss of hearing; bloody urine; confusion; convulsions (seizures); diarrhea (severe or continuing); difficultyin swallowing; dizziness, lightheadedness, or feelingfaint (severe); drowsiness (severe); excitement or nervousness (severe); fast or deep breathing; flushing, redness, or otherchange in skin color; hallucinations (seeing, hearing,or feeling things that are not there); increasedsweating; increased thirst; nausea or vomiting (severe or continuing); shortnessof breath, troubled breathing, tightness in chest, or wheezing; stomach pain (severe or continuing); swelling of eyelids, face, or lips; unexplained fever; uncontrollable flapping movements of the hands(especially in elderly patients); vision problems

        Symptoms 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

        Abdominal or stomach pain, cramping, or burning (severe); bloody or black, tarry stools; headache(severe or continuing); ringing or buzzing in ears(continuing); skin rash, hives, or itching; unusual tiredness or weakness; vomitingof blood or material that looks like coffee grounds

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your health care professional if any of the following side effectscontinue or are bothersome:

    More common

      Abdominal or stomach cramps, pain, or discomfort (mild to moderate); heartburn or indigestion; nausea or vomiting

    Less common

      Trouble in sleeping, nervousness, or jitters (only for productscontaining caffeine)

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


Revised: 08/04/2005