Pain-Off Oral

In Depth

Generic Name: ASPIRIN/ACETAMINOPHEN/CAFFEINE - ORAL
Pronounced: (AS-pir-in/ah-seet-ah-MIN-oh-fen/KAF-een)

Pain-Off Oral Side Effects

Nausea, vomiting, stomach upset, trouble falling asleep, or a shaky/nervous feeling may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and tell your doctor immediately if any of these unlikely but serious side effects occur:

severe dizziness
fainting
persistent or worsening stomach pain
vomit that looks like coffee grounds
black/bloody stools
ringing in the ears
loss of hearing
irregular/fast heartbeat
change in the amount of urine
signs of infection (e.g., persistent sore throat or fever)
easy bruising/bleeding

This medication contains acetaminophen. Do not take this product with other medications containing acetaminophen or take more acetaminophen than recommended. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams (4000 milligrams) per day. If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, seek immediate medical attention :

persistent nausea/vomiting
yellowing eyes or skin
dark urine
unusual/extreme tiredness

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

rash
itching/swelling (especially of the face/tongue/throat)
severe dizziness
trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. In the US, you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.

In Canada, you may report side effects to Health Canada at 1-866-234-2345.