Febrol (Oral, Rectal)

Acetaminophen is used to relieve minor aches and pains and to lower fever. It may also help with pain from mild types of arthritis.

You can get this medicine without a prescription.

It is very important for your doctor to check how you or your child is doing while using this medicine. This helps your doctor see if the medicine is working correctly and to decide if you should keep taking it.

If your symptoms or fever do not get better in a few days or if they get worse, contact your doctor.

Many combination medicines have acetaminophen in them, including products with brand names like Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Taking these medicines along with what you already take may lead to a higher than safe amount of acetaminophen. Talk to your doctor before taking more than one medicine that has acetaminophen.

Contact 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 signs of a serious liver issue.

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

Acetaminophen may affect the results of some medical tests. Before you have any medical tests, inform the person in charge if you have taken acetaminophen in the last 3 or 4 days. You can also call the laboratory ahead of time to check if acetaminophen will cause any issues.

Acetaminophen may lead to false results in some blood glucose tests. If you have diabetes and notice a change in your test results, or if you have any questions, consult your doctor.

If you think you have taken too much acetaminophen, seek emergency help immediately, even if there are no signs of poisoning. Treatment to prevent liver damage needs to start as soon as possible.

In deciding to use this medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems in children that would limit the usefulness of acetaminophen. However, do not give over-the-counter products to children under 2 years of age unless your doctor advises you to do so.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of acetaminophen.

Breast Feeding

Research suggests that this medication poses minimal risk to infants when used by breastfeeding women.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. If you are taking this medicine, it is important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

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

Using this medicine with any of the following may increase the risk of certain side effects, but may still be necessary. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both 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 certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant and may not include all possible interactions.

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 adjust the dose or frequency for this medicine or provide special instructions regarding food, alcohol, or tobacco.

• Ethanol
• Tobacco

Using this medicine with any of the following may increase the risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency for this medicine or provide special instructions regarding food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Alcohol abuse, or a history of it
• Severe kidney disease
• Liver disease (including hepatitis)—May worsen side effects.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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)
• Severe and/or sharp pain in the lower back and/or side
• Pinpoint red spots on the skin
• Skin rash, hives, or itching
• Sore throat (not present before treatment and not caused by the condition being treated)
• Sores, ulcers, or white spots on the lips or in the mouth
• Sudden decrease in urine output
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Yellowing of the eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

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

Other side effects not listed may also occur in some patients. If you notice any other effects, consult 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.

In the U.S.

• Acephen
• Actamin Maximum Strength
• Altenol
• Aminofen
• Anacin Aspirin Free
• Apra
• Arthritis Pain Relief
• Cetafen
• Children's Mapap
• Children's Nortemp
• Comtrex Sore Throat Relief
• Dolono
• Febrol
• Feverall
• Genapap
• Genebs
• Infantaire
• Mapap
• Mapap Arthritis Pain
• Pain-Eze +/Rheu-Thritis
• Pyrecot
• Pyregesic
• Q-Pap
• Redutemp
• Silapap
• T-Painol
• Tycolene
• Tylenol

In Canada

• Abenol
• Acetaminophen
• Actimol Children's
• Actimol Infant
• Atasol
• Atoma Acetaminophen Arthritis Pain
• Atoma Children's Acetaminophen - Dye Free- Cherry
• Atoma Children's Acetaminophen Suspension - Bubble Gum
• Basic Care Acetaminophen - Arthritis Pain
• Biomedic Acetaminophen Arthritis Pain
• Children's Acetaminophen
• Children's Acetaminophen - Grape

Available Dosage Forms:

• Capsule, Liquid Filled
• Solution
• Powder
• Tablet, Chewable
• Suppository
• Liquid
• Elixir
• Suspension
• Tablet
• Capsule
• Tablet, Extended Release
• Tablet, Disintegrating

Therapeutic Class: Analgesic

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.

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