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Generic Name: acetaminophen, caffeine, and phenyltoloxamine (a SEET a MIN o fen KAF een, FEN il toe LOX a meen)
What is 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.
Acetaminophen, caffeine, and phenyltoloxamine is a combination medicine 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.
Acetaminophen, caffeine, and phenyltoloxamine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about acetaminophen, caffeine, and phenyltoloxamine?
Do not take more of this medication 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 this medicine 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.
What should I discuss with my health care provider before taking this medicine?
You should not use this medication 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 this medicine 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;
heart disease, high blood pressure, or recent heart attack;
enlarged prostate or urination problems;
FDA pregnancy category C. It is not known whether acetaminophen, caffeine, and phenyltoloxamine 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 this medicine.
Do not give this medicine to a child without medical advice.
How should I take this medicine?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not take more of this medication 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 at room temperature away from moisture and heat.
What happens if I miss a dose?
Since this medicine 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.
What happens if I overdose?
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.
What should I avoid while taking this medicine?
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.
This medicine 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.
This medicine side effects
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.
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 this medicine 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 this medicine 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 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.
What other drugs will affect acetaminophen, caffeine, and phenyltoloxamine?
Other drugs may interact with acetaminophen, caffeine, and phenyltoloxamine, 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.
See also: Side effects (in more detail)
More about Flextra (acetaminophen / caffeine / phenyltoloxamine)
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- Dosage Information
- Drug Interactions
- Support Group
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- Drug class: analgesic combinations
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Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, caffeine, and phenyltoloxamine.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2013-10-28, 2:52:01 PM.