Pain Reliever Plus

Acetaminophen helps relieve pain and reduce fever. Aspirin is a salicylate (sa-LIS-il-ATE). Caffeine acts as a stimulant for the central nervous system.

Pain Reliever Plus is a combination medicine that treats pain from tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Do not use aspirin for heart or blood vessel conditions unless your doctor instructs you to.

Pain Reliever Plus may also be used for other purposes not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Never use more than the recommended dose. An overdose of acetaminophen can damage your liver or cause death.

Take with food or milk if the medicine upsets your stomach.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever lasting longer than 3 days, or any swelling or pain lasting longer than 10 days.

Overuse of migraine headache medicine (more than 10 days per month) can make headaches worse. Tell your doctor if this medicine seems to stop working as well.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Pain Reliever Plus.

If you need surgery, dental work, or a medical procedure, you may need to stop taking this medicine for a short time.

Store at room temperature away from moisture and heat.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, which is a serious and sometimes fatal condition in children.

Do not take more than the recommended dose. An acetaminophen overdose can damage your liver or cause death.

Call your doctor at once if you have: nausea, upper stomach pain, loss of appetite, dark urine, yellowing of your skin or eyes, clay-colored stools, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, which is a serious and sometimes fatal condition in children.

You should not use this medicine if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (diclofenac, ibuprofen, indomethacin, meloxicam, naproxen, Advil, Aleve, Motrin, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can happen without warning while you are taking this medicine.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• asthma or seasonal allergies;
• fever with a stiff neck;
• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;
• bleeding problems;
• kidney disease; or
• if you use medicine to treat glaucoma or prevent blood clots.

If you take Pain Reliever Plus to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;
• a headache that causes vomiting;
• what feels like the worst headache you've ever had;
• a headache that seems different from your usual headaches;
• a headache every day;
• a headache after coughing, bending, exercising, or head injury;
• if you have never had migraines diagnosed by a doctor; or
• if you are having your first headache after age 50.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Ask a doctor before using this medicine if you are pregnant.

Do not give this medicine to anyone younger than 18 years old without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This can happen even if you have taken acetaminophen before without any problems. Stop taking this medicine and call your doctor right away if you notice skin redness or a rash that spreads and causes blistering and peeling. If you experience this kind of reaction, you should never take any medicine that contains acetaminophen again.

This medicine may cause serious side effects. Stop using this medicine and call your doctor immediately if you have:

• severe anxiety, agitation, confusion, panic;
• easy bruising or bleeding;
• a light-headed feeling, like you might pass out;
• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Pain Reliever Plus may include:

• upset stomach, heartburn;
• depressed mood, feeling anxious or restless; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since Pain Reliever Plus is taken as needed, you might not follow a specific dosing schedule. If you miss a dose and it’s almost time for your next one, just skip the missed dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much acetaminophen can harm your liver or lead to death.

Early signs of acetaminophen overdose include not wanting to eat, feeling sick to your stomach, vomiting, sweating, or feeling weak. Later symptoms can include pain in the upper stomach, dark urine, and yellowing of your skin or eyes.

Other overdose symptoms may include ringing in your ears, headache, diarrhea, seeing or hearing things that aren’t there, a fast or slow heartbeat, or seizures (convulsions).

Do not drink alcohol. It may increase your chances of liver damage or stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may have ingredients similar to acetaminophen or aspirin (like ibuprofen, ketoprofen, or naproxen).

Do not consume coffee, tea, cola, energy drinks, or other sources of caffeine while taking this medication. They can increase the side effects of the caffeine in the medication.

Other drugs may interact with Pain Reliever Plus, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any medicine you begin or discontinue using.