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Acetaminophen/ caffeine/ magnesium salicylate/ phenyltoloxamine

Generic Name: acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine (ah-seet-ah-MIN-oh-fen/ka-FEEN/mag-NEE-zhum sa-LI-si-late/fen-ill-tole-OX-a-meen)
Brand Name: Durabac Forte

Acetaminophen/ caffeine/ magnesium salicylate/ phenyltoloxamine is used for:

Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, muscle spasms, nerve pain, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis. It helps restore mental alertness or wakefulness during periods of fatigue or drowsiness. It may also be used for other conditions as determined by your doctor.

Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine is an analgesic, antipyretic, salicylate, antihistamine, and stimulant combination. It works by decreasing fever, pain, and inflammation. It also blocks histamine, which causes allergy symptoms (eg, sneezing and itchy, watery eyes).

Do NOT use acetaminophen/ caffeine/ magnesium salicylate/ phenyltoloxamine if:

  • you are allergic to any ingredient in acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine
  • you are allergic to salicylates (eg, aspirin) or NSAIDs (eg, ibuprofen)
  • you have kidney or liver problems, bleeding problems (eg, hemophilia, active severe bleeding), low blood platelet levels, or Von Willebrand disease
  • the patient is a child or teenager who has flu symptoms or chickenpox
  • you are also taking an anticoagulant (eg, warfarin) or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using acetaminophen/ caffeine/ magnesium salicylate/ phenyltoloxamine:

Some medical conditions may interact with acetaminophen/caffeine/magnesium salicylate/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 breathing problems (eg, asthma), blood clotting problems, stomach or intestinal problems (eg, ulcer, blockage, inflammation), prostate problems, urinary blockage, trouble urinating, increased pressure in the eyes (eg, glaucoma), heart or blood vessel problems, high blood pressure, viral hepatitis, anxiety, trouble sleeping, growths in the nose, low blood vitamin K levels, influenza, or chickenpox
  • if the patient is a child who has a history of stroke, a bulging blood vessel in the brain (aneurysm), an inflammatory condition (rheumatic disease), or Kawasaki syndrome
  • if you have taken furazolidone or a monamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

Some MEDICINES MAY INTERACT with acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinides (eg, nateglinide), sodium oxybate (GHB), sympathomimetics (eg, albuterol, pseudoephedrine), theophyllines (eg, aminophylline), or valproic acid because the risk of their side effects may be increased by acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine
  • Anticoagulants (eg, warfarin) because the risk of bruising or bleeding may be increased
  • Barbiturates (eg, phenobarbital) because they may decrease acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine's effectiveness
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver.
  • Furazolidone, isoniazid, MAO inhibitors (eg, phenelzine), or quinolone antibiotics (eg, ciprofloxacin) because they may increase the risk of acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine's side effects
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), aspirin, probenecid, or sulfinpyrazone because their effectiveness may be decreased by acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if acetaminophen/caffeine/magnesium salicylate/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/ magnesium salicylate/ phenyltoloxamine:

Use acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of acetaminophen/caffeine/magnesium salicylate/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/magnesium salicylate/phenyltoloxamine.

Important safety information:

  • Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine may harm your liver. Your risk may be greater if you drink alcohol while you are using acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine. Talk to your doctor before you take acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine or other fever reducers if you drink more than 3 drinks with alcohol per day.
  • 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/magnesium salicylate/phenyltoloxamine has a salicylate in it. Before you start any new medicine, check the label to see if it has a salicylate in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).
  • Diabetes patients - Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • If you are taking acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine for pain and your symptoms do not improve within 10 days or if they become worse or if redness is present, check with your doctor.
  • Tell your doctor or dentist that you take acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine before you receive any medical or dental care, emergency care, or surgery.
  • Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine has a salicylate in it, which has been linked to a serious illness called Reye syndrome. Do not give acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
  • Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine.
  • Use acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine with caution in the ELDERLY; they may be more sensitive to its effects, especially anemia or liver or kidney problems.
  • Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine while you are pregnant. Acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine is found in breast milk. Do not breast-feed while taking acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine.

Possible side effects of acetaminophen/ caffeine/ magnesium salicylate/ 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:

Anxiety; blurred vision; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; fast heartbeat; headache; heartburn; irritability; loss of appetite; nausea; nervousness; thickening of mucus in the nose and throat; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

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 coordination; decreased urination; difficulty swallowing; fainting; fever, chills, persistent sore throat, or other signs of infection; hearing loss; hoarseness; irregular heartbeat; muscle weakness; ringing in the ears; seizures; severe or persistent heartburn; severe, persistent, or recurring fast heartbeat; severe stomach pain; severe vomiting; shortness of breath; tremors; unusual bruising or bleeding; unusual tiredness; vomit that looks like coffee grounds; 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; confusion; dark urine; delirium; difficulty hearing; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; seizures; severe or persistent dizziness, nausea, or vomiting; stomach pain; yellowing of the skin or eyes.

Proper storage of acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine:

Store acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine out of the reach of children and away from pets.

General information:

  • If you have any questions about acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine, please talk with your doctor, pharmacist, or other health care provider.
  • Acetaminophen/caffeine/magnesium salicylate/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/magnesium salicylate/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/magnesium salicylate/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/magnesium salicylate/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/magnesium salicylate/phenyltoloxamine.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.

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