Uses of Acetaminophen, Aspirin, and Caffeine Powder Packet:

• It is used to treat migraine headaches.
• It is used to ease pain.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Acetaminophen, Aspirin, and Caffeine Powder Packet?

For all patients taking acetaminophen, aspirin, and caffeine powder packet:

• If you have an allergy to acetaminophen, aspirin, caffeine, or any other part of acetaminophen, aspirin, and caffeine powder packet.
• If you are allergic to acetaminophen, aspirin, and caffeine powder packet; any part of acetaminophen, aspirin, and caffeine powder packet; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
• If you have bleeding problems.
• If you are taking another drug that has the same drug in it.
• If you are taking any other NSAID.
• If you are pregnant or may be pregnant. Do not take acetaminophen, aspirin, and caffeine powder packet if you are in the third trimester of pregnancy. You may also need to avoid acetaminophen, aspirin, and caffeine powder packet at other times during pregnancy. Talk with your doctor to see when you need to avoid taking acetaminophen, aspirin, and caffeine powder packet during pregnancy.

Children:

• If your child or teenager has or is getting better from flu signs, chickenpox, or other viral infections. The risk of a very bad problem called Reye's syndrome may be raised. Do not give acetaminophen, aspirin, and caffeine powder packet to a child or teenager who has or is getting better from a viral infection.

This is not a list of all drugs or health problems that interact with acetaminophen, aspirin, and caffeine powder packet.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acetaminophen, aspirin, and caffeine powder packet with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Acetaminophen, Aspirin, and Caffeine Powder Packet?

• Tell all of your health care providers that you take acetaminophen, aspirin, and caffeine powder packet. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take acetaminophen, aspirin, and caffeine powder packet for longer than you were told by your doctor.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
• This medicine has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen.
• Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Be careful if you have G6PD deficiency. Anemia may happen.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with acetaminophen, aspirin, and caffeine powder packet may cause nervousness, shakiness, and a fast heartbeat.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take acetaminophen, aspirin, and caffeine powder packet.
• If you are 60 or older, use acetaminophen, aspirin, and caffeine powder packet with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking acetaminophen, aspirin, and caffeine powder packet, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Acetaminophen, Aspirin, and Caffeine Powder Packet) best taken?

Use acetaminophen, aspirin, and caffeine powder packet as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Place the powder on your tongue and follow with a full glass of water or other liquid. You may also mix the powder with water and drink.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Feeling confused.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Ringing in ears.
• Hearing loss.
• Very bad headache or if headache is not better after the first dose.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad stomach ulcers or bleeding can happen with acetaminophen, aspirin, and caffeine powder packet. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking acetaminophen, aspirin, and caffeine powder packet with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

What are some other side effects of Acetaminophen, Aspirin, and Caffeine Powder Packet?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or heartburn.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Acetaminophen, Aspirin, and Caffeine Powder Packet?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about acetaminophen, aspirin, and caffeine powder packet, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.