Flextra

Generic Name: acetaminophen, caffeine, and phenyltoloxamine (a SEET a MIN o fen KAF een, FEN il toe LOX a meen)
Brand Names: Flextra

What is Flextra?

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Flextra is an orange colored capsule that contains a combination of acetaminophen, caffeine, and phenyltoloxamine.

Flextra is used to treat mild to moderate pain and discomfort caused by headache, the common cold, muscle or joint pain, nerve pain, sinus pain, tooth pain, menstrual pain, or minor aches and pains of arthritis.

Flextra may also be used for purposes other than those listed in this medication guide.

Important information about Flextra

Acetaminophen is a non-aspirin pain reliever. Caffeine is a stimulant that helps restore mental alertness. Phenyltoloxamine is an antihistamine that blocks the chemical in your body that produces allergy symptoms such as sneezing and runny nose.

Do not use Flextra for longer than 10 days unless your doctor has told you to.

Do not take more than six (6) capsules in a 24-hour period. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Before taking Flextra

Do not use Flextra if you are allergic to acetaminophen (Tylenol), caffeine, or phenyltoloxamine. Do not use Flextra without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to use acetaminophen.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Flextra:

• asthma;

• an allergy to aspirin;

• kidney disease;

• liver disease;

• a stomach disorder such as an ulcer or obstruction;

• urination or prostate problems; or

• a history of blood clots.

FDA pregnancy category C. It is not known whether Flextra is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use Flextra without telling your doctor if you are breast-feeding a baby.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Flextra.

Do not give Flextra to a child younger than 12 years old.

How should I take Flextra?

Take Flextra exactly as it was prescribed for you. Do not take it in larger doses or take it for longer than 10 days unless your doctor has told you to. Follow the directions on your prescription label.

Do not take more than six (6) capsules in a 24-hour period. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day. Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much Flextra.

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.

Overdose symptoms may also include tremors (uncontrolled shaking); increased heart rate; confusion or restless feeling; fever, loss of appetite, and seizure (convulsions).

What should I avoid while taking Flextra?

Avoid drinking alcohol, which can increase some of the side effects of Flextra. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

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

Flextra can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Flextra side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Flextra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeat;

• easy bruising, unusual bleeding or weakness;

• feeling light-headed, fainting;

• urinating less than usual;

• increased thirst and increased urination;

• muscle weakness, lack of coordination; or

• jaundice (yellowing of the skin or eyes).

Less serious Flextra side effects may include:

• feeling nervous or irritable;

• sleep problems (insomnia);

• dizziness or drowsiness;

• dry mouth, nose or throat;

• mild itching or skin rash;

• upset stomach, nausea, cramps, or diarrhea;

• trouble concentrating; or

• blurred vision.

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.

What other drugs will affect Flextra?

Before taking Flextra, tell your doctor if you are using any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• phenobarbital; or

• aspirin.

This list is not complete and there may be other drugs that can interact with Flextra. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Flextra.

What does my medication look like?

Acetaminophen, caffeine, and phenyltoloxamine is available with a prescription under the brand name Flextra. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about Flextra, especially if it is new to you.

• Flextra 425/35/45 mg - orange capsule

• Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2009 Cerner Multum, Inc. Version: 1.04. Revision Date: 07/28/2009 3:58:52 PM.

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