Actamin Maximum Strength

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
• Children's Acetaminophen
• Children's Acetaminophen Bubble Gum Flavor
• Children's Acetaminophen Cherry Flavor
• Children's Acetaminophen - Grape
• Children's Acetaminophen Grape Flavor
• Children's Acetaminophen Suspension Bubble Gum Flavor - Ages 2 To 11
• Children's Acetaminophen Suspension Cherry Flavor

Available Dosage Forms:

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

Therapeutic Class: Analgesic

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 Actamin Maximum Strength. 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.

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:

• 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 the lower back and/or side (severe and/or sharp)
• 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 the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

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

• 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, 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.

There are many brands and forms of acetaminophen available. Not all brands are listed on this leaflet.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Acetaminophen may also be used for purposes not listed in this medication guide.

Since acetaminophen is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, acetaminophen (the active ingredient contained in Actamin) 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 while taking acetaminophen:

• 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 the lower back and/or side (severe and/or sharp)
• 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 the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

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

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area