What is the most important information I should know about acetaminophen, caffeine, and phenyltoloxamine?
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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. |
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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.
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Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. |
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Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. |
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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?
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You should not use this medication if you are allergic to acetaminophen (Tylenol) or phenyltoloxamine (RhinoFlex, Percogesic, Acuflex, and others). |
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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. |
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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).
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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. |
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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. |
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Acetaminophen, caffeine, and phenyltoloxamine should not be given to a child younger than 12 years old. |
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?
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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?
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Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. |
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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. |
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Avoid using other sources of caffeine, such as coffee, tea, or caffeinated soft drinks. |
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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?
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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. |
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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?
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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.
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