Amigesic Advanced Patient Information - Drugs.com

Skip to main content
Print

# Amigesic

Generic name: salicylate (oral route, rectal route)

## Commonly used brand name(s)

In the U.S.

- Amigesic
- Azulfidine
- Azulfidine Entabs
- Bayer
- Canasa
- Colazal
- Dipentum
- Doan's Extra Strength
- Doan's Regular
- Dolobid
- Ecotrin
- Giazo
- Kaopectate
- Pentasa
- Pepto Bismol
- Salflex
- Tricosal
- Trilisate

In Canada

- Asacol 800
- Bismuth Extra Strength
- Bismuth Original Formula
- Compliments Bismuth - Regular Strength
- Exact Bismuth - Extra Strength
- Exact Bismuth - Regular Strength
- GoodSense Bismuth - Regular Strength
- Life Brand Bismuth - Extra Strength
- Life Brand Bismuth - Regular Strength
- Mesasal
- Option+ Bismuth - Regular Strength

Available Dosage Forms:

- Tablet
- Liquid
- Tablet, Delayed Release
- Suppository
- Capsule, Delayed Release
- Capsule, Extended Release
- Enema
- Tablet, Enteric Coated
- Suspension
- Tablet, Chewable
- Capsule, Liquid Filled
- Capsule
- Capsule, Extended Release, 24 HR

## Uses for Amigesic

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 effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.

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

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

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

## Importance of Diet

Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (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 mg of sodium in each 650-mg tablet.

## Before using Amigesic

### Allergies

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

### Pediatric

Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with 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 medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.

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

### Geriatric

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

### Pregnancy

Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.

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

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

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

### Breastfeeding

Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).

Caffeine passes into the breast milk in small amounts.

### Interactions with medicines

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

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

- Abrocitinib
- Defibrotide
- Dichlorphenamide
- Influenza Virus Vaccine, Live
- Ketorolac
- Methenamine

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

- Abciximab
- Acarbose
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acetazolamide
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amoxicillin
- Amtolmetin Guacil
- Anagrelide
- Anisindione
- Apixaban
- Ardeparin
- Argatroban
- Aspirin
- Azathioprine
- Balsalazide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Betamethasone
- Betrixaban
- Bismuth Subsalicylate
- Bivalirudin
- Bromfenac
- Budesonide
- Bufexamac
- Bumetanide
- Cangrelor
- Caplacizumab-yhdp
- Capmatinib
- Celecoxib
- Certoparin
- Chlorothiazide
- Chlorpropamide
- Chlorthalidone
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Cilostazol
- Citalopram
- Clomipramine
- Clonixin
- Clopamide
- Clopidogrel
- Cortisone
- Cyclopenthiazide
- Cyclosporine
- Dabigatran Etexilate
- Dalteparin
- Danaparoid
- Darolutamide
- Deflazacort
- Desipramine
- Desirudin
- Desmopressin
- Desvenlafaxine
- Dexamethasone
- Dexibuprofen
- Dexketoprofen
- Diazoxide
- Dibenzepin
- Diclofenac
- Dicumarol
- Diflunisal
- Digoxin
- Dipyridamole
- Dipyrone
- Dothiepin
- Doxepin
- Droxicam
- Duloxetine
- Edoxaban
- Enasidenib
- Encorafenib
- Enoxaparin
- Eplerenone
- Epoprostenol
- Eptifibatide
- Escitalopram
- Ethacrynic Acid
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Feverfew
- Floctafenine
- Flufenamic Acid
- Fluocortolone
- Fluoxetine
- Flurbiprofen
- Fluvoxamine
- Fondaparinux
- Furosemide
- Ginkgo
- Glimepiride
- Glipizide
- Glyburide
- Gossypol
- Heparin
- Hydrochlorothiazide
- Hydrocortisone
- Hydroflumethiazide
- Ibrutinib
- Ibuprofen
- Iloprost
- Imipramine
- Indapamide
- Indomethacin
- Inotersen
- Ketoprofen
- Leflunomide
- Lepirudin
- Levomilnacipran
- Lithium
- Lofepramine
- Lornoxicam
- Loxoprofen
- Lumiracoxib
- Macimorelin
- Magnesium Salicylate
- Meadowsweet
- Meclofenamate
- Mefenamic Acid
- Melitracen
- Meloxicam
- Mercaptopurine
- Mesalamine
- Metformin
- Methotrexate
- Methyclothiazide
- Methylprednisolone
- Metolazone
- Midostaurin
- Milnacipran
- Morniflumate
- Nabumetone
- Nadroparin
- Naproxen
- Nateglinide
- Nefazodone
- Nepafenac
- Nicorandil
- Niflumic Acid
- Nimesulide
- Nimesulide Beta Cyclodextrin
- Nortriptyline
- Olsalazine
- Opipramol
- Oxaprozin
- Oxyphenbutazone
- Paramethasone
- Parecoxib
- Parnaparin
- Paroxetine
- Pemetrexed
- Pentosan Polysulfate Sodium
- Pentoxifylline
- Phenindione
- Phenprocoumon
- Phenylbutazone
- Phenyl Salicylate
- Piketoprofen
- Piracetam
- Piroxicam
- Polythiazide
- Porfimer
- Potassium Citrate
- Pranoprofen
- Prasugrel
- Prednisolone
- Prednisone
- Proglumetacin
- Propyphenazone
- Proquazone
- Protein C
- Protriptyline
- Reboxetine
- Repaglinide
- Reteplase, Recombinant
- Reviparin
- Rivaroxaban
- Rofecoxib
- Salicylamide
- Salicylic Acid
- Salsalate
- Selumetinib
- Sertraline
- Sibutramine
- Sodium Salicylate
- Spironolactone
- Sulfasalazine
- Sulindac
- Sulodexide
- Tacrolimus
- Tafamidis
- Tenofovir Disoproxil Fumarate
- Tenoxicam
- Teriflunomide
- Tianeptine
- Tiaprofenic Acid
- Ticagrelor
- Ticlopidine
- Tinzaparin
- Tirofiban
- Tolazamide
- Tolbutamide
- Tolfenamic Acid
- Tolmetin
- Torsemide
- Trazodone
- Treprostinil
- Triamterene
- Trichlormethiazide
- Trimipramine
- Trolamine Salicylate
- Valdecoxib
- Varicella Virus Vaccine, Live
- Venlafaxine
- Vilazodone
- Vorapaxar
- Vortioxetine
- Warfarin
- Xipamide

### Interactions with food/tobacco/alcohol

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

### Other medical problems

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

- Anemia or
- Overactive thyroid or
- Stomach ulcer or other stomach problems—Salicylates may make your 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 also lessen 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 of heart disease worse.

- Hemophilia or other bleeding problems—The chance of bleeding may be increased, especially with aspirin.

## Proper use of Amigesic

This section provides information on the proper use of a number of products that contain salicylate. It may not be specific to Amigesic. Please read with care.

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

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

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

- Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.
- If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.
- Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.
- There are several different forms of aspirin or buffered aspirin tablets. If you are using:
  - chewable aspirin tablets, they may be chewed, 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 up before taking.
  - extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them 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 refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
- To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to 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 them up 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 more than 5 times a day.

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

### Dosing

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

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

For aspirin
- For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
  - For pain or fever:
    - Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.
    - Children 11 to 12 years of age—320 to 480 mg every four hours as needed.
    - Children 9 to 11 years of age—320 to 400 mg every four hours as needed.
    - Children 6 to 9 years of age—320 to 325 mg every four hours as needed.
    - Children 4 to 6 years of age—240 mg every four hours as needed.
    - Children 2 to 4 years of age—160 mg every four hours as needed.
    - Children up to 2 years of age—Dose must be determined by your doctor.
  - For arthritis:
    - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
    - Children—A total of 80 to 100 mg per kilogram (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 by blood clots:
    - Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin 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 dosage form (chewing gum):
  - For pain:
    - Adults and teenagers—2 tablets every four hours as needed.
    - Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.
    - Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.
    - Children up to 3 years of age—Dose must be determined by your doctor.
- For long-acting oral dosage form (extended-release tablets):
  - For pain:
    - Adults and teenagers—1 or 2 tablets twice a day.
    - Children—The long-acting aspirin tablets are too strong for use 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 for use in children.
- For rectal dosage form (suppositories):
  - For pain or fever:
    - Adults and teenagers—325 to 650 mg every four hours as needed.
    - Children 11 to 12 years of age—325 to 480 mg every four hours as needed.
    - Children 9 to 11 years of age—325 to 400 mg every four hours as needed.
    - Children 6 to 9 years of age—325 mg every four hours as needed.
    - Children 4 to 6 years of age—240 mg every four hours as needed.
    - Children 2 to 4 years of age—160 mg every four hours as needed.
    - Children up to 2 years of age—Dose must be determined by your doctor.
  - For arthritis:
    - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
    - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.

For aspirin and caffeine
- For oral dosage forms (capsule):
  - For pain or fever:
    - Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
    - Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
    - Children 6 to 9 years of age—325 mg every four hours as needed.
    - Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age
  - For preventing a heart attack, stroke, or other problems caused by blood clots:
    - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin 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 dosage form (tablets):
  - For pain or fever:
    - Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
    - Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
    - Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.
  - For arthritis:
    - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a 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 by blood clots:
    - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin 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 forms (tablets):
  - For pain or fever:
    - Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
    - Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.
    - Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
    - Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.
    - Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
    - Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
    - Children up to 2 years of age—Dose must be determined by your doctor.
  - For arthritis:
    - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
    - Children—A total of 80 to 100 mg per kilogram (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 by blood clots:
    - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin 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 aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.
    - Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.
    - Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
    - Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.
    - Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
    - Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
    - Children up to 2 years of age—Dose must be determined by your doctor.
  - For arthritis:
    - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
    - Children—A total of 80 to 100 mg per kilogram (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 by blood clots:
    - Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may 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 teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.
    - Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special 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 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 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
    - Children up to 2 years of age—Dose must be determined by your doctor.
  - For arthritis:
    - Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.
    - Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.

For choline and magnesium salicylates
- For oral dosage forms (oral solution or 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 more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.
    - Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.

For magnesium salicylate
- For oral dosage form (tablets):
  - For pain:
    - Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight 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 three times 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 four hours as needed.
    - Children 6 years of age and older—325 mg every four hours as needed.
    - Children up to 6 years of age—This medicine is too strong for use in children younger than 6 years of age.
  - For arthritis:
    - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
    - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.

### Missed dose

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

### Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

## Precautions while using Amigesic

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 skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with this medicine may cause an overdose.

If you will be taking salicylates for a long time (more than 5 days in a 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. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor 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 lasts for more than 10 days (5 days for children) or if the pain gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs medical or dental treatment.
- If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, if the fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.
- If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed 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. Your doctor may want to change the amount of medicine you are taking every day.

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

- Take only the amount of aspirin ordered by your doctor. 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 discuss this with your doctor, so that you will know ahead of time what medicine to take.
- Do not stop taking this medicine for any reason without first checking with the doctor who directed you to take it.

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

- 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 taking large amounts of salicylates, such as:
  - Aspirin: 8 or more 325-mg (5-grain), or 4 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 or more 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more 1000-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, or 3 or more 750-mg doses, a day.
- Smaller doses or occasional use of salicylates usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
  - you are not sure how much salicylate you are taking every day.
  - you notice any change in your urine sugar test results.
  - you have any other questions about this possible problem.

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

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

- Buffered aspirin, choline and magnesium salicylates, or magnesium salicylate can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your health care professional how long you should wait between taking a medicine for infection and taking buffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too 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 alcoholic beverages while being treated with this medicine, especially if you are taking it in high doses or for a long time. Check with your doctor if you have any questions about this.

For patients using aspirin suppositories:

- Aspirin suppositories may cause irritation of the rectum. Check with your doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the 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 how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for at least 8 to 12 hours before the test.

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

## Amigesic side effects

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

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

Symptoms of overdose in children

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

- Any loss of hearing
- bloody urine
- confusion
- convulsions (seizures)
- diarrhea (severe or continuing)
- difficulty in swallowing
- dizziness, lightheadedness, or feeling faint (severe)
- drowsiness (severe)
- excitement or nervousness (severe)
- fast or deep breathing
- flushing, redness, or other change in skin color
- hallucinations (seeing, hearing, or feeling things that are not there)
- increased sweating
- increased thirst
- nausea or vomiting (severe or continuing)
- shortness of 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

Check with your doctor as 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
- vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 products containing caffeine)

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

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

## Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer