Aspirin and caffeine is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.

Caffeine is used in this product to increase the pain relieving effects of aspirin and caffeine.

Aspirin and caffeine is a combination product used to treat headaches, muscle pain, minor arthritis pain, and fever or body aches caused by the common cold. Aspirin and caffeine is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin and caffeine should be used for cardiovascular conditions only under the supervision of a doctor.

Aspirin and caffeine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to aspirin or caffeine, or if you have:

• a recent history of stomach or intestinal bleeding;
• active bleeding caused by hemophilia or another blood-clotting disorder; or
• an allergy to an NSAID (nonsteroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

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

This medicine may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking aspirin and caffeine, especially:

• if you are age 60 or older;
• if you have a stomach ulcer or a history of stomach or intestinal bleeding;
• if take a blood thinner (warfarin, Coumadin) or steroid medicine;
• if you drink more than 3 alcoholic beverages per day; or
• if you take the medicine for longer than recommended.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• any bleeding disorder or stomach problems;
• heart disease, high blood pressure;
• asthma or seasonal allergies;
• liver or kidney disease;
• gout; or
• diabetes.

This medicine may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin and caffeine.

Aspirin and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Use Adult Strength (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Stop using aspirin and caffeine and call your doctor at once if you have:

• ringing in your ears, confusion, hallucinations, rapid breathing, seizure (convulsions);
• severe nausea, vomiting, or stomach pain;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• fever lasting longer than 3 days; or
• swelling, or pain lasting longer than 10 days.

Common side effects may include:

• upset stomach, heartburn;
• drowsiness; or
• mild headache.

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.

If you are taking aspirin and caffeine to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin and caffeine less effective. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin and caffeine (non-enteric coated form).

Avoid drinking alcohol while you are taking aspirin and caffeine. Alcohol may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any cold or allergy medicine, diet pills, or pain medication. Many medicines available over the counter contain aspirin or caffeine. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, naproxen, or caffeine.

Ask your doctor before using aspirin and caffeine if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.