Abenol

Acetaminophen is used to treat minor aches and pain and to reduce fever. It may also help treat pain from mild forms of arthritis.

This medicine is available without a prescription.

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of acetaminophen in children. However, do not give over-the-counter products to children under 2 years of age unless instructed to do so by your doctor.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen in the elderly.

Pregnancy

Breast Feeding

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

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 this medicine, 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 this medicine 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.

• Imatinib
• Isoniazid
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate

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
• Fosphenytoin
• Lixisenatide
• Phenytoin
• Warfarin
• Zidovudine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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
• Tobacco

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 history of or
• Kidney disease, severe or
• Liver disease (including hepatitis)—May cause side effects to become worse.

• Phenylketonuria (PKU)—Some brands of acetaminophen contain aspartame, which can make this condition worse.

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Liver damage can occur if large amounts of acetaminophen are taken for a long time.

If you are taking this medicine without the advice of your doctor, carefully read the package label and follow the dosing instructions. Talk to your doctor if you have any questions.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems. For Tylenol® Extra Strength, the maximum dose is 3,000 milligrams per 24 hours.

You may take this medicine with or without food.

For patients using the oral liquid with syringe (e.g. Little Fevers®):

• Shake the bottle well before each use.
• Measure the dose with the provided dose syringe (e.g., AccuSafe™) that comes with the package. Do not use any other syringe, dropper, spoon, or dosing device when giving this medicine to your child.
• Remove the cap, attach the syringe to the flow restrictor, and invert the bottle.
• Pull back the syringe until filled with the dose prescribed by your doctor.
• Slowly give the medicine into your child's mouth (towards the inner cheek).
• Replace and tighten the cap.

For patients using the oral liquid with dropper:

• Shake the bottle well before each use.
• Measure the dose with the provided dropper. Do not use any other syringe, dropper, spoon, or dosing device when giving this medicine to your child.
• Remove the cap, insert the dropper and withdraw the dose prescribed by your doctor.
• Slowly give the medicine into your child's mouth (towards the inner cheek).
• Replace the cap back tightly.

For patients using 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.

For patients using 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 (5 mL) 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:
  • Remove the foil wrapper and moisten the suppository with cold water.
  • Lie down on your side and use your finger to push the suppository 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 pain or fever:
  • For oral and rectal dosage forms (capsules, granules, powders, solution, suppositories, suspension, or tablets):
    • Adults and teenagers—650 to 1000 milligrams (mg) every 4 to 6 hours as needed. Dose is based on form and strength. Carefully follow the label instructions for the maximum dose per day.
    • Children—Dose is based on weight or age. Carefully follow the label instructions for the maximum dose per day.
      • Children 11 to 12 years of age: 320 to 480 mg every 4 to 6 hours as needed.
      • Children 9 to 11 years of age: 320 to 400 mg every 4 to 6 hours as needed.
      • Children 6 to 9 years of age: 320 mg every 4 to 6 hours as needed.
      • Children 4 to 6 years of age: 240 mg every 4 to 6 hours as needed.
      • Children 2 to 4 years of age: 160 mg every 4 to 6 hours as needed.
      • Children under 2 years of age: Use and dose must be determined by your doctor.

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

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your symptoms or fever do not improve within a few days or if they become worse, check with your doctor.

Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Adding these medicines to the medicine you already take may cause you to get more than a safe amount of acetaminophen. Talk to your doctor before taking more than one medicine that contains acetaminophen.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

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 alcohol on a regular basis, if you take more acetaminophen than is recommended on the label, or if you take it regularly for a long time.

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. You may also call the laboratory ahead of time to find out whether acetaminophen will cause a problem.

Acetaminophen may cause false results with some blood glucose tests. If you are diabetic and notice a change in your test results, or if you have any questions, check with your doctor.

If you think you have taken too much acetaminophen, get emergency help at once, even if there are no signs of poisoning. Treatment to prevent liver damage must be started as soon as possible.

Applies to acetaminophen: compounding powder, intravenous solution, oral capsule, oral granule effervescent, oral liquid, oral powder for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, rectal suppository

General

In general, acetaminophen (the active ingredient contained in Abenol) is well-tolerated when administered in therapeutic doses. The most commonly reported adverse reactions have included nausea, vomiting, constipation. Injection site pain and injection site reaction have been reported with the IV product.[Ref]

Hepatic

Common (1% to 10%): Increased aspartate aminotransferase
Rare (less than 0.1%): Increased hepatic transaminases
Frequency not reported: Liver failure[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), Vomiting (up to 15%)
Common (1% to 10%): Abdominal pain, diarrhea, constipation, dyspepsia, enlarged abdomen
Frequency not reported: Dry mouth[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, hypersensitivity reactions[Ref]

Hematologic

Common (1% to 10%): Anemia, postoperative hemorrhage
Very rare (less than 0.01%): Thrombocytopenia, leucopenia, neutropenia[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Very rare (less than 0.01%): Pemphigoid reaction, pustular rash, Lyell syndrome
:[Ref]

Respiratory

Common (1% to 10%): Dyspnea, abnormal breath sounds, pulmonary edema, hypoxia, pleural effusion, stridor, wheezing, coughing[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, hypertension, hypotension, tachycardia, chest pain[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, hyperglycemia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Dystonia

Musculoskeletal

Common (1% to 10%): Muscle spasms, trismus

Psychiatric

Common (1% to 10%): Insomnia, anxiety

Genitourinary

Common (1% to 10%): Oliguria

Local

Common (1% to 10%): Infusion site pain, injection site reactions

Ocular

Common (1% to 10%): Periorbital edema

Other

Common (1% to 10%): Pyrexia, fatigue
Rare (0.01% to 0.1%): Malaise

Some side effects of Abenol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Doses may be given as a single or repeated dose as follows:

Parenteral:
Weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 4000 mg per 24 hours

Weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 75 mg/kg per 24 hours

Oral:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours

Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours

Rectal:
650 mg rectally every 4 to 6 hours
Maximum dose: 3900 mg per 24 hours

Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed

Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.

In pregnant rats receiving oral drug at doses up to 0.85 times maximum human daily dose (MHDD) during organogenesis, fetotoxicity and dose-related increases in bone variations (reduced ossification and rudimentary rib changes) were observed. Areas of necrosis in both the liver and kidney of pregnant rats and fetuses were observed when pregnant rats were given oral drug throughout gestation at doses 1.2 times the maximum human daily dose. Animal studies using the IV formulation have not been performed. Epidemiologic data, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took this drug as either an over the counter or prescription product at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. In a prospective birth cohort study (Avon Longitudinal Study or Parents and Children [ALSPAC]) maternal drug exposure was assessed by questionnaire at 18 and 32 weeks, children were assessed at 61 months. Mothers were questioned about behavioral problems in their children at 7 years old; children's behavioral problems were assessed using the Strengths and Difficulties Questionnaire (SDQ). A number of confounders were evaluated although a limitation of the study was lack of information for drug use. The authors suggest there may be an association between drug use during pregnancy and behavioral problems in childhood that may be due to an intrauterine mechanism. Further studies are needed to test alternatives to a causal explanation. There are no controlled data in human pregnancy. According to published animal studies, acetaminophen may cause reduced fertility in both males and females described as decreased testicular weights, reduced spermatogenesis, reduced fertility; and reduced implantation sites, respectively. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Benefit should outweigh risk AU TGA pregnancy category: A US FDA pregnancy category: Not Assigned Risk Summary: A clear association of drug use and birth defects, miscarriage, or adverse maternal or fetal outcomes has not been shown with human use; animal studies have demonstrated adverse events at clinically relevant doses.

Substance Name

Acetaminophen

CAS Registry Number

103-90-2

Drug Class

Analgesics, Non-Narcotic

LactMed Record Number

330

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.