Abenol

Unlike aspirin, it does not relieve the redness, stiffness, or swelling caused by rheumatoid arthritis . However, it may relieve the pain caused by mild forms of arthritis .

This medicine is available without a prescription.

This product is available in the following dosage forms:

• Solution


• Tablet, Disintegrating


• Suppository


• Powder


• Syrup


• Tablet


• Tablet, Chewable


• Capsule


• Powder for Solution


• Suspension


• Elixir


• Tablet, Extended Release


• Capsule, Liquid Filled


• Liquid


• Tablet, Effervescent

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults. However, some children`s products containing acetaminophen also contain aspartame, which may be dangerous if it is given to children with phenylketonuria.

Geriatric

Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Carbamazepine


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

Other Interactions

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

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

• Alcohol abuse or


• Kidney disease (severe) or


• Hepatitis or other liver diseasea€”The chance of serious side effects may be increased

• Phenylketonuriaa€”Some brands of acetaminophen contain aspartame, which can make your condition worse

Proper Use

Unless otherwise directed by your medical doctor or dentist :

• Do not take more of this medicine than is recommended on the package label. If too much is taken, liver and kidney damage may occur.


• Children up to 12 years of age should not take this medicine more than 5 times a day.

To use acetaminophen oral granules (e.g., Snaplets-FR):

• Just before the medicine is to be taken, open the number of packets needed for one dose . Mix the granules inside of the packets with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen granules along with the food.

To use acetaminophen oral powders (e.g., Feverall Sprinkle Caps [Children`s or Junior Strength]):

• These capsules are not intended to be swallowed whole. Instead, just before the medicine is to be taken, open the number of capsules needed for one dose . Empty the powder from each capsule into 1 teaspoonful of water or other liquid . Drink the medicine along with the liquid . You may drink more liquid after taking the medicine. You may also mix the powder with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen powder along with the food.

For patients using acetaminophen 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 .
  
  
  
  

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage forms (capsules, granules, powders, solution, suspension, or tablets) and rectal dosage forms (suppositories):
  
  
  
  • For pain or fever:
    
    
    
    • Adults and teenagersa€”325 or 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.The total dose should not be more than 4000 mg (for example, eight 500a€“mg tablets) a day.
    
    
    • Childrena€”Acetaminophen dose is based on the child`s age.
      
      
      
      • Infants up to 3 months of age: 40 mg every four hours as needed.
      
      
      • Infants 4 to 12 months of age: 80 mg every four hours as needed.
      
      
      • Children 1 to 2 years of age: 120 mg every four hours as needed.
      
      
      • 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 mg every four hours as needed.
      
      
      • Children 9 to 11 years of age: 320 to 400 mg every four hours as needed.
      
      
      • Children 11 to 12 years of age: 320 to 480 mg every four hours as needed.
      
      
      
      
    
    
    
    
  
  
  
  

Storage

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

Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze .

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Check with your medical doctor or dentist:

• If you are taking this medicine to relieve pain, including arthritis pain, and the pain lasts for more than 10 days for adults or 5 days for children or if the pain gets worse, new symptoms occur, or the painful area is red or swollen. 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, the fever gets worse, new symptoms occur, or 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 .

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

If you will be taking more than an occasional 1 or 2 doses of acetaminophen, do not drink alcoholic beverages. To do so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly, if you take more acetaminophen than is recommended on the package label, or if you take it regularly for a long time.

Taking certain other medicines together with acetaminophen 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 medical doctor or dentist 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 acetaminophen for more than a few days unless your doctor has directed you to do so and is following your progress:

• Aspirin or other salicylates


• Diclofenac (e.g., Voltaren)


• Diflunisal (e.g., Dolobid)


• Etodolac (e.g., Lodine)


• Fenoprofen (e.g., Nalfon)


• Floctafenine (e.g., Idarac)


• Flurbiprofen, oral (e.g., Ansaid)


• Ibuprofen (e.g., Motrin)


• Indomethacin (e.g., Indocin)


• Ketoprofen (e.g., Orudis)


• Ketorolac (e.g., Toradol)


• Meclofenamate (e.g., Meclomen)


• Mefenamic acid (e.g., Ponstel)


• Nabumetone (e.g., Relafen)


• Naproxen (e.g., Naprosyn)


• Oxaprozin (e.g., Daypro)


• Phenylbutazone (e.g., Butazolidin)


• Piroxicam (e.g., Feldene)


• Sulindac (e.g., Clinoril)


• Tenoxicam (e.g., Apo-Tenoxicam)


• Tiaprofenic acid (e.g., Surgam)


• Tolmetin (e.g., Tolectin)

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

For diabetic patients:

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

For patients taking one of the products that contain caffeine in addition to acetaminophen:

• Caffeine may interfere with the results 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 8 to 12 hours before the test .

If you think that you or anyone else may have taken an overdose of acetaminophen, get emergency help at once, even if there are no signs of poisoning. Signs of severe poisoning may not appear for 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started as soon as possible. Treatment started more than 24 hours after the overdose is taken may not be effective .

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 .

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

Rare

• Yellow eyes or skin

Symptoms of overdose

• Diarrhea


• Increased sweating


• Loss of appetite


• Nausea or vomiting


• Stomach cramps or pain


• Swelling, pain, or tenderness in the upper abdomen or stomach area

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Bloody or black, tarry stools


• Bloody or cloudy urine


• Fever with or without chills (not present before treatment and not caused by the condition being treated)


• Pain in lower back and/or side (severe and/or sharp)


• Pinpoint red spots on skin


• Skin rash, hives, or itching


• Sores, ulcers, or white spots on lips or in mouth


• Sore throat (not present before treatment and not caused by the condition being treated)


• Sudden decrease in amount of urine


• Unusual bleeding or bruising


• Unusual tiredness or weakness

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.