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Acetaminophen/ caffeine/ phenyltoloxamine
Generic Name: acetaminophen/caffeine/phenyltoloxamine (ah-seet-ah-MIN-oh-fen/ka-FEEN/fen-ill-tole-OX-a-meen)
Brand Name: Flextra
Acetaminophen/ caffeine/ phenyltoloxamine is used for:
Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, backache, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis. It may also be used for other conditions as determined by your doctor.
Acetaminophen/caffeine/phenyltoloxamine is an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.
Do NOT use acetaminophen/ caffeine/ phenyltoloxamine if:
- you are allergic to any ingredient in acetaminophen/caffeine/phenyltoloxamine
- you have lung problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), difficulty urinating due to an enlarged prostate, glaucoma, or blood clotting problems
- you are taking medicine for blood clotting or sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
Before using acetaminophen/ caffeine/ phenyltoloxamine:
Some medical conditions may interact with acetaminophen/caffeine/phenyltoloxamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have bleeding problems, blood vessel problems in the brain, blockage of the stomach or bowel, kidney or liver problems, chickenpox, flu, rheumatoid arthritis, Kawasaki syndrome, prostate problems, blockage of the bladder, or difficulty urinating
Some MEDICINES MAY INTERACT with acetaminophen/caffeine/phenyltoloxamine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Isoniazid, sodium oxybate (GHB), sympathomimetics (eg, pseudoephedrine), or theophyllines (eg, aminophylline) because the risk of side effects may be increased
- Blood thinners (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased
- Barbiturates (eg, phenobarbital) because the effectiveness of acetaminophen/caffeine/phenyltoloxamine may be decreased
This may not be a complete list of all interactions that may occur. Ask your health care provider if acetaminophen/caffeine/phenyltoloxamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use acetaminophen/ caffeine/ phenyltoloxamine:
Use acetaminophen/caffeine/phenyltoloxamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Acetaminophen/caffeine/phenyltoloxamine may be taken with or without food.
- If you miss a dose of acetaminophen/caffeine/phenyltoloxamine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use acetaminophen/caffeine/phenyltoloxamine.
Important safety information:
- Acetaminophen/caffeine/phenyltoloxamine may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to acetaminophen/caffeine/phenyltoloxamine. Using acetaminophen/caffeine/phenyltoloxamine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking acetaminophen/caffeine/phenyltoloxamine. Acetaminophen/caffeine/phenyltoloxamine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
- Acetaminophen/caffeine/phenyltoloxamine may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take acetaminophen/caffeine/phenyltoloxamine or other pain relievers/fever reducers. Alcohol use combined with acetaminophen/caffeine/phenyltoloxamine may increase your risk for liver damage.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Acetaminophen/caffeine/phenyltoloxamine contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.
- Do not exceed the recommended dosage or take acetaminophen/caffeine/phenyltoloxamine for longer than prescribed without checking with your doctor.
- Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate.
- If you are taking acetaminophen/caffeine/phenyltoloxamine for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using acetaminophen/caffeine/phenyltoloxamine.
- Acetaminophen/caffeine/phenyltoloxamine is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been established.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using acetaminophen/caffeine/phenyltoloxamine during pregnancy. Acetaminophen/caffeine/phenyltoloxamine is excreted in breast milk. Do not breast-feed while taking acetaminophen/caffeine/phenyltoloxamine.
Possible side effects of acetaminophen/ caffeine/ phenyltoloxamine:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; drowsiness; dry mouth, nose, or throat; heartburn; nausea; nervousness; thickening of mucus in the nose and throat; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black stools; confusion; dark urine or pale stools; decreased urination; diarrhea; difficulty swallowing; dizziness; hearing loss; hoarseness; persistent sore throat or other signs of infection; ringing in the ears; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.Proper storage of acetaminophen/caffeine/phenyltoloxamine:
Store at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep acetaminophen/caffeine/phenyltoloxamine out of the reach of children and away from pets.
- If you have any questions about acetaminophen/caffeine/phenyltoloxamine, please talk with your doctor, pharmacist, or other health care provider.
- Acetaminophen/caffeine/phenyltoloxamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take acetaminophen/caffeine/phenyltoloxamine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about acetaminophen/caffeine/phenyltoloxamine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acetaminophen/caffeine/phenyltoloxamine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using acetaminophen/caffeine/phenyltoloxamine.