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  • acetaminophen, caffeine, and phenyltoloxamine
 

acetaminophen, caffeine, and phenyltoloxamine

Pronunciation: a SEET a MIN o fen KAF een, FEN il toe LOX a meen

Brand: Flextra Plus

What is the most important information I should know about acetaminophen, caffeine, and phenyltoloxamine?

Multum donot

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid.

Multum emt

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.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Multum donot

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

Multum noalcohol

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

Multum donot

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.

What is acetaminophen, caffeine, and phenyltoloxamine?

Acetaminophen is a pain reliever and fever reducer.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen.

Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of acetaminophen, caffeine, and phenyltoloxamine 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.

Acetaminophen, caffeine, and phenyltoloxamine may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking acetaminophen, caffeine, and phenyltoloxamine?

Multum donot

You should not use this medication if you are allergic to acetaminophen (Tylenol) or phenyltoloxamine (RhinoFlex, Percogesic, Acuflex, and others).

Multum donot

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Multum emt

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 you can safely take acetaminophen, caffeine, and phenyltoloxamine, tell your doctor if you have any of these other conditions:

  • a blockage in your digestive tract (stomach or intestines);
  • a blockage in your digestive tract (stomach or intestines);
  • liver or kidney disease;
  • cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
  • enlarged prostate or urination problems;
  • low blood pressure;
  • a stomach ulcer; or
  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
Multum nopreg

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.

Multum nobrfeed

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

Multum nochild

Acetaminophen, caffeine, and phenyltoloxamine should not be given to a child younger than 12 years old.

How should I take acetaminophen, caffeine, and phenyltoloxamine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Multum donot

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

Multum emt

Do not take for longer than 10 days in a row (or 5 days if treating a child). 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.

Multum rt

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since acetaminophen, caffeine, and phenyltoloxamine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Multum emt

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.

Overdose symptoms may also include tremors (uncontrolled shaking), fast heart rate, restless feeling, fever, and seizure (convulsions).

What should I avoid while taking acetaminophen, caffeine, and phenyltoloxamine?

Multum noalcohol

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

Multum donot

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.

Multum nocoffee

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

Multum dizzy

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.

What are the possible side effects of acetaminophen, caffeine, and phenyltoloxamine?

Multum emt

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.

Multum donot

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeat;
  • easy bruising or bleeding, unusual weakness;
  • black, 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;
  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • 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).

Less serious side effects may include:

  • dizziness, drowsiness;
  • sleep problems (insomnia);
  • feeling nervous;
  • blurred vision;
  • dry mouth, nose or throat;
  • mild itching or skin rash;
  • upset stomach, constipation; or
  • memory problems.

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?

Multum dizzy

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by phenyltoloxamine.

Tell your doctor about all other medicines you use, especially:

  • leflunomide (Arava);
  • tizanadine (Zanaflex);
  • topiramate (Topamax);
  • zonisamide (Zonegran);
  • an antibiotic, antifungal medicine, or tuberculosis medicine;
  • a barbiturate such as phenobarbital (Solfoton);
  • birth control pills or hormone replacement therapy;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cancer medications;
  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;
  • gout or arthritis medications (including gold injections);
  • blood pressure medication;
  • HIV/AIDS medication;
  • medicines to treat psychiatric disorders;
  • NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or
  • seizure medication.

This list is not complete and other drugs may interact with acetaminophen, caffeine, and phenyltoloxamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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.

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 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 12/7/2011.

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