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ACETAMINOPHEN; ASPIRIN; CAFFEINE (a set a MEE noe fen; AS pir in; KAF een) treats mild aches and pains. It is a combination of acetaminophen, an NSAID, and caffeine.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the label. You can take it with or without food. If it upsets your stomach, take it with food. Do not use it more often than directed.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

People 65 years and older may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use. It should only be used as needed.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Hearing loss, ringing in ears
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Round red or dark patches on the skin that may itch, burn, and blister

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Anxiety, nervousness
• Headache
• Loss of appetite
• Nausea
• Tremors or shaking
• Trouble sleeping
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anemia
• Anxiety or panic attacks
• Asthma
• Bleeding problems
• Diabetes
• Frequently drink alcohol
• Gout
• Heart disease
• High blood pressure
• Kidney disease
• Liver disease
• Low level of vitamin K in your blood
• Lupus
• Stomach ulcers, other stomach or intestine problems
• Tobacco use
• An unusual or allergic reaction to acetaminophen, aspirin, caffeine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methotrexate
• Other medications with acetaminophen
• Probenecid

This medication may also interact with the following:

• Alcohol
• Alendronate
• Bismuth subsalicylate
• Clozapine
• Flavocoxid
• Grapefruit juice
• Herbal supplements, such as feverfew, garlic, ginger, ginkgo biloba, horse chestnut
• Isoniazid
• Lithium
• Medications for diabetes or glaucoma, such as acetazolamide, methazolamide
• Medications for gout
• Medications that stimulate or keep you awake
• Medications that prevent or treat blood clots, such as enoxaparin, heparin, ticlopidine, warfarin
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Other aspirin and aspirin-like medications
• Some cough and cold medications, such as pseudoephedrine
• Varicella live vaccine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if the pain lasts more than 10 days, if it gets worse, or if there is a new or different kind of pain. Tell your care team if you see redness or swelling. If you are treating a fever, check with your care team if the fever lasts for more than 3 days.

Do not take Tylenol (acetaminophen) or medications that have acetaminophen with this medication. Too much acetaminophen can be very dangerous. Always read medication labels carefully.

Report any possible overdose to your care team right away, even if there are no symptoms. The effects of extra doses may not be seen for many days.

This medication can irritate your stomach or cause bleeding problems. Do not smoke cigarettes or drink alcohol. Do not lie down for 30 minutes after taking this medication to prevent irritation to your throat.

If you are scheduled for any medical or dental procedure, tell your care team that you are taking this medication. You may need to stop taking this medication before the procedure.

Do not take this medication close to bedtime. It may prevent you from sleeping.

This medication may be used to treat migraines. If you take migraine medications for 10 or more days a month, your migraines may get worse. Keep a diary of headache days and medication use. Contact your care team if your migraine attacks occur more frequently.