Bayer Back and Body 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.

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

Bayer Back and Body may also be used for purposes not listed in this medication guide.

Aspirin may cause stomach or intestinal bleeding, which can be fatal.

Aspirin can also cause a severe allergic reaction. Get emergency medical help if you have hives, wheezing, or swelling in your face, lips, tongue, or throat.

You should not use Bayer Back and Body if you have an active bleeding disorder such as hemophilia.

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

Use 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.

Take with food if Bayer Back and Body upsets your stomach.

Dissolve the powder or effervescent tablet in at least 4 ounces of water. Stir and drink this mixture right away.

If you need surgery, tell the surgeon ahead of time that you are using Bayer Back and Body. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the Bayer Back and Body bottle. The medicine may no longer be effective.

Store at room temperature away from moisture and heat.

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. Bayer Back and Body 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 Bayer Back and Body, 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 Bayer Back and Body.

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

Since Bayer Back and Body is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Avoid drinking alcohol while you are taking Bayer Back and Body. 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 Bayer Back and Body 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.

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.

Bayer Back and Body may cause serious side effects. Stop using Bayer Back and Body 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 of Bayer Back and Body 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.

Other drugs may interact with aspirin and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.