Acetaminophen/caffeine/phenyltoloxamine/salicylamide (By mouth)

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Acetaminophen (a-seet-a-MIN-oh-fen), Caffeine (KAF-een), Phenyltoloxamine (fen-il-tol-OX-a-meen), Salicylamide (sal-i-SIL-a-mide)

Treats mild to moderate pain, including headache and muscle or joint pain. This medicine also helps maintain mental alertness when you feel tired or drowsy.

Brand Name(s)

Durabac, Cafgesic

When This Medicine Should Not Be Used

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using phenobarbital, aspirin, asthma medicine (such as salbutamol, terbutaline, albuterol, Ventolin®), or a blood thinner such as warfarin (Coumadin®).
• Avoid food, drinks, or other medicine that contains caffeine. If you take them together with this medicine, you may get too much caffeine and have unwanted side effects.
• Many combination medicines contain acetaminophen. Carefully check the labels of all other medicines you are using to be sure they do not contain acetaminophen. Using too much of these medicines can cause serious side effects.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have asthma, glaucoma, heart problems, high blood pressure, bleeding problems, enlarged prostate, trouble urinating, or stomach ulcer or any stomach problem.
• If your symptoms do not improve within 10 days, or if they get worse, call your doctor.
• Do not give this medicine to your child or teenager who has fever, chicken pox, or symptoms of an infection unless your doctor tells you to.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burning pain on your throat or chest.
• Change in how much or how often you urinate.
• Fast or pounding heartbeat.
• Increased thirst or hunger.
• Lightheadedness, dizziness, drowsiness, or fainting.
• Rapid breathing.
• Seizures or tremors.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Changes in vision.
• Dry mouth, throat, or nose.
• Headache or confusion.
• Irritability, nervousness, increased sweating, or trouble sleeping.
• Nausea, vomiting, diarrhea, stomach cramps, or upset stomach.
• Skin rash or itching.
• Trouble hearing, or ringing in your ears.
• Warmth or redness in your face, neck, arms, or upper chest.

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This combination medicine contains acetaminophen (Tylenol(R)). Carefully check the labels of all other medicines you are using because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• Swallow the capsule whole. Do not crush, break, or chew it.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.