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Acetaminophen, caffeine, and phenyltoloxamine

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

What is acetaminophen, caffeine, and phenyltoloxamine?

Acetaminophen is a pain reliever and fever reducer.

Caffeine is a stimulant.

Phenyltoloxamine is an antihistamine.

The combination of acetaminophen, caffeine, and phenyltoloxamine 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.

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

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

Do not use this medication 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.

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

Do not use this medication if you are allergic to acetaminophen (Tylenol), caffeine, or phenyltoloxamine. Do not use this medication 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 this medication:

  • 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 acetaminophen, caffeine, and phenyltoloxamine 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 this medication 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 acetaminophen, caffeine, and phenyltoloxamine.

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

How should I take acetaminophen, caffeine, and phenyltoloxamine?

Take this medication 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 of this medicine.

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 acetaminophen, caffeine, and phenyltoloxamine?

Avoid drinking alcohol, which can increase some of the side effects of this medication. 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.

Acetaminophen, caffeine, and phenyltoloxamine 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.

Acetaminophen, caffeine, and phenyltoloxamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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.

Acetaminophen, caffeine, and phenyltoloxamine Dosing Information

Usual Adult Dose for Cold Symptoms:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Adult Dose for Pain:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Adult Dose for Sinusitis:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Adult Dose for Headache:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Cold Symptoms:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Pain:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Sinusitis:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Headache:

APAP/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

What other drugs will affect acetaminophen, caffeine, and phenyltoloxamine?

Before taking this medication, 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 acetaminophen, caffeine, and phenyltoloxamine. 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 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 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 07/28/2009 3:58:52 PM.;
 
 
 
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