Flextra Plus contains a combination of acetaminophen, caffeine, and phenyltoloxamine. Acetaminophen is a pain reliever and fever reducer. Caffeine can help increase the pain relieving effects of acetaminophen. Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body.

Flextra Plus is used to treat mild pain and discomfort caused by headache, muscle aches, back pain, tooth pain, menstrual pain, arthritis, or the common cold or flu.

Flextra Plus may also be used for purposes not listed in this medication guide.

Do not take more Flextra Plus than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

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

Acetaminophen is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Take Flextra Plus exactly as prdirected by your health care professional. Follow all directions on the label. Do not take Flextra Plus in larger or smaller amounts or for longer than recommended.

Do not take more Flextra Plus than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, if your symptoms get worse, or if you have any redness or swelling.

Store Flextra Plus at room temperature away from moisture and heat.

You should not use Flextra Plus if you are allergic to acetaminophen or phenyltoloxamine.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

To make sure Flextra Plus is safe for you, tell your doctor if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• a blockage in your stomach or intestines;

• liver disease or a history of alcoholism;

• kidney disease;

• heart disease, high blood pressure, or recent heart attack;

• enlarged prostate or urination problems;

• glaucoma; or

• overactive thyroid.

FDA pregnancy category C. It is not known whether Flextra Plus will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen, caffeine, and phenyltoloxamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Flextra Plus.

Do not give Flextra Plus to a child without medical advice.

Since Flextra Plus 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. An overdose of acetaminophen can damage your liver.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other pain, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid using other sources of caffeine, such as coffee, tea, or caffeinated soft drinks.

Flextra Plus may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Flextra Plus and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using Flextra Plus and call your doctor at once if you have:

• fast or pounding heartbeat;

• easy bruising or bleeding, unusual weakness;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• trouble swallowing, increased thirst and urination;

• severe diarrhea or stomach pain;

• confusion, ringing in your ears, hearing problems;

• a light-headed feeling, like you might pass out;

• little or no urinating;

• muscle weakness, loss of coordination; or

• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Common Flextra Plus side effects may include:

• dizziness, drowsiness, memory problems;

• nervous feeling, sleep problems (insomnia);

• blurred vision, dry mouth, nose or throat;

• upset stomach, constipation; or

• mild itching or skin rash.

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 Flextra Plus, 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.