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Generic name: acetaminophen/salicylamide/phenyltoloxamine/caffeine (a-seet-a-MIN-oh-fen/SAL-i-SIL-a-mide/FEN-il-tole-OX-a-meen/KAF-een)
Brand name: Examples include Cafgesic and Durabac

Cafgesic is used for:

Treating minor aches and pains (eg, headache, muscle or joint soreness, minor toothache, menstrual cramps). It is also used to treat symptoms associated with certain conditions (eg, colds, arthritis, muscle spasm, sinusitis). It may also be used for other conditions as determined by your doctor.

Cafgesic 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 Cafgesic if:

  • you are allergic to any ingredient in Cafgesic
  • you have had a severe allergic reaction to aspirin or other salicylates (eg, rash, hives, itching, difficulty breathing, tightness in the chest)
  • you have kidney or liver problems
  • you are a child or teenager and have a viral infection (eg, chickenpox, flu, cold)
  • you are taking sodium oxybate (GHB) or an anticoagulant (eg, warfarin)

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

Before using Cafgesic:

Some medical conditions may interact with Cafgesic. 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 a viral infection (eg, chickenpox, flu); Kawasaki syndrome; ulcers; a blockage of your stomach, bowel, or bladder; blood or bleeding problems; blood clotting problems; heart problems; blood vessel problems; or high blood pressure.
  • if you have a history of lung or breathing problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), increased pressure in the eye, glaucoma, difficulty urinating, prostate problems (eg, enlarged prostate), anxiety, trouble sleeping, or high blood sugar
  • if you drink alcohol, have a history of alcohol abuse or dependence, or take a monoamine oxidase inhibitor (MAOI) (eg, phenelzine)

Some MEDICINES MAY INTERACT with Cafgesic. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Sodium oxybate (GHB) because serious side effects such as prolonged sedation and severe drowsiness may occur
  • Anticoagulants (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased
  • Aspirin, isoniazid, MAOIs (eg, phenelzine), or quinolones (eg, ciprofloxacin) because they may increase the risk of Cafgesic's side effects
  • Theophylline because the risk of its side effects may be increased by Cafgesic
  • Barbiturates (eg, phenobarbital) because their effectiveness may be decreased by Cafgesic

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cafgesic 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 Cafgesic:

Use Cafgesic as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Cafgesic by mouth with or without food.
  • If you miss a dose of Cafgesic and you are taking 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 Cafgesic.

Important safety information:

  • Cafgesic may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Cafgesic 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 Cafgesic; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • If you are taking Cafgesic for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.
  • Cafgesic has acetaminophen, caffeine, an aspirin-like medicine, and an antihistamine in it. Before you start any new medicine, check the label to see if it has any of these ingredients in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Cafgesic contains caffeine. Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).
  • Cafgesic may harm your liver or cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Cafgesic. Talk to your doctor before you take Cafgesic 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.
  • Tell your doctor or dentist that you take Cafgesic before you receive any medical or dental care, emergency care, or surgery.
  • Do not give Cafgesic to a child or teenager who has chickenpox, the flu, or another viral infection. Use of Cafgesic for treating the symptoms of a viral infection may cause a serious illness called Reye syndrome.
  • Cafgesic may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Cafgesic.
  • Use Cafgesic with caution in the ELDERLY; they may be more sensitive to its effects, especially liver and kidney problems.
  • Cafgesic 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: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cafgesic while you are pregnant. Cafgesic is found in breast milk. Do not breast-feed while taking Cafgesic.

Possible side effects of Cafgesic:

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:

Dizziness; drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

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; blurred vision or other vision changes; dark urine; decrease in the amount of urine produced; difficulty urinating; fainting; fast or irregular heartbeat; hearing loss; involuntary trembling; loss of coordination; pale stools; ringing in the ears; seizures; severe or persistent dizziness; severe stomach pain; trouble sleeping; 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 thoughts or behavior; confusion; dark urine; excessive sweating; fast or deep breathing; fast or irregular heartbeat; general discomfort; hearing loss; high fever; involuntary trembling; ringing in the ears; seizures; severe or persistent stomach pain; trouble sleeping; vomiting; yellowing of the eyes or skin.

Proper storage of Cafgesic:

Store Cafgesic 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 Cafgesic out of the reach of children and away from pets.

General information:

  • If you have any questions about Cafgesic, please talk with your doctor, pharmacist, or other health care provider.
  • Cafgesic 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 Cafgesic 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 Cafgesic. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cafgesic. 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 Cafgesic.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.