Generic Name: acetaminophen, caffeine, and phenyltoloxamine (a SEET a MIN o fen KAF een, FEN il toe LOX a meen)Brand Names: Flextra
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:
an allergy to aspirin;
a stomach disorder such as an ulcer or obstruction;
urination or prostate problems; or
a history of blood clots.
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.
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.
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.
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).
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.
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
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.
Before taking this medication, tell your doctor if you are using any of the following drugs:
a blood thinner such as warfarin (Coumadin);
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.