Acetaminophen (a-seet-a-MIN-oh-fen), Caffeine (KAF-een), Phenyltoloxamine (fen-il-tol-OX-a-meen), Salicylamide (sal-i-SIL-a-mide)

Treats mild to moderate pain, and helps maintain alertness.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• Swallow the capsule whole. Do not crush, break, or chew it.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how this medicine works. Tell your doctor if you are taking any of the following:
  • A blood thinner, such as warfarin
  • Aspirin
  • Asthma medicine, such as salbutamol, terbutaline, albuterol
  • Medicine that contains acetaminophen
  • Medicine that contains caffeine
  • Phenobarbital
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk. If you regularly drink 3 or more alcoholic drinks every day, do not take any medicines that contain acetaminophen without asking your doctor. A drink of alcohol is 12 ounces of beer, 4 ounces of wine, or 1 ounce of liquor.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Tell your doctor if you have liver or kidney disease, asthma, glaucoma, heart problems, high blood pressure, bleeding problems, an enlarged prostate, trouble urinating, or a stomach ulcer.
• If your symptoms do not improve within 10 days, or if they get worse, call your doctor.
• This medicine can cause a rare but serious illness called Reye syndrome in children and teenagers. Do not give this medicine to a child or teenager younger than 18 years, unless your doctor has told you to. If the child or teenager has behavior changes along with nausea and vomiting, call his doctor right away.
• This medicine may make you dizzy or drowsy. Do not drive or use machines if you are not alert.
• Carefully check the labels of all other medicines you are taking to be sure they do not contain acetaminophen. Too much acetaminophen can cause serious side effects.
• Do not have food, drinks, or other medicines that contain caffeine. Too much caffeine can cause unwanted side effects.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Fast or pounding heartbeat
• Increased thirst or hunger, along with headache and confusion
• Lightheadedness, dizziness, drowsiness, or fainting
• Rapid breathing
• Seizures or tremors
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Changes in vision
• Dry mouth, throat, or nose
• Irritability, nervousness, increased sweating, or trouble sleeping
• Nausea, vomiting, diarrhea, stomach cramps, or upset stomach
• Skin rash, itching, or warmth or redness in your face, neck, arms, or chest
• Trouble hearing, or ringing in your ears

If you notice other side effects that you think are caused by this medicine, tell your doctor

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