Drugs & Vitamins

Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide capsules Active Ingredients: Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide capsules Representative Names: Cafgesic, Durabac What are Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide capsules? What should I tell my health care provider before I take this medicine? How should this medicine be used? What if I miss a dose? What drug(s) may interact with Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide? What side effects may I notice from receiving Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide? What should I watch for while taking Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide? Where can I keep my medicine? What are Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide capsules? (Back to top) ACETAMINOPHEN; CAFFEINE; PHENYLTOLOXAMINE; SALICYLAMIDE (Durabac®, Cafgesic®) is used to relieve mild to moderate pain. It treats symptoms such as headache, muscle or nerve pain, or pain and discomfort from the common cold, flu, or sinus infection. It may also be used to treat pain from menstrual cramps or arthritis. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •anemia or other blood or clotting disease •asthma, emphysema, bronchitis, or other lung disease •difficulty passing urine or other bladder problems •drink more than 3 alcohol-containing drinks per day •enlarged prostate •glaucoma •heart disease including angina, history of heart attack, blockage in heart vessels, heart failure •high blood pressure •irregular heart beat •kidney disease •liver disease •poor circulation (peripheral vascular disease) •problems with immune system •smoke tobacco products •stomach problems like ulcers or bleeding •vitamin K deficiency •an unusual reaction to acetaminophen, caffeine, phenyltoloxamine, salicylamide, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should this medicine be used? (Back to top) Take this medicine by mouth. Follow the directions on the prescription label. Swallow each dose with plenty of water. This medicine may be taken with food or milk if upset stomach occurs. Do not take it more often than directed. Do not share this medicine with anyone. Patients over 60 years old may have a stronger reaction to this medicine. Smaller doses may be needed. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you are taking this medicine regularly and miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. What drug(s) may interact with Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide? (Back to top) •amphetamine, cocaine, or other stimulant drugs •antacids •aspirin or similar medicines •atomoxetine •atropine •bretylium •busulfan •caffeine •carbamazepine or oxcarbazepine •cholestyramine •cyclopropane •diuretics •herbal supplements like green tea extract, echinacea, feverfew, guarana or St. John's wort •imatinib •isoniazid •lamotrigine •mecamylamine •medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®) •medicines for depression or other mental problems, especially tricyclic antidepressants (e.g., Elavil®, Pamelor®) •medicines for chest pain, heart disease, high blood pressure, or heart rhythm problems •medicines for diabetes •medicines used for migraines (ergotamine, dihydroergotamine, ergonovine, methysergide) •medicines used to treat or prevent blood clots •medicines for mental problems and psychotic disturbances •medicines for movement abnormalities such as Parkinson's disease •medicines for rheumatoid arthritis or other autoimmune disorders •medicines for weight loss (including some herbal products, ephedrine, dextroamphetamine) •medicines used to relieve diarrhea or constipation •midodrine •phenytoin or fosphenytoin •prilocaine •procarbazine •probenecid •rifampin •rifabutin •some antibiotics and antiviral medicines •steroids like prednisone or cortisone •sulfinpyrazone •vitamin C products •warfarin Because this product can cause drowsiness, other medicines that also cause drowsiness may increase this effect. Some medicines that cause drowsiness are: •alcohol and alcohol-containing medicines •barbiturate medicines for inducing sleep or treating seizures (convulsions) •medicines for anxiety or sleeping problems, such as diazepam or temazepam •other medicines for allergies, such as antihistamines or decongestants •medicines for motion sickness or nausea/ vomiting •muscle relaxers •prescription pain medicines Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from receiving Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •agitation, nervousness, excitability, not able to sleep (these are more likely in children) •bluish discoloration of lips, fingernails, or palms of hands •chest pain •confusion •difficulty breathing or wheezing •difficulty urinating •headache, especially if severe or gets worse •high blood pressure •irregular heart beat •nausea and vomiting •ringing in the ears or changes in hearing •seizures •signs or symptoms of bleeding from the stomach or intestine such as black, tarry stools, stomach pain, vomiting up blood, or what looks like coffee grounds •skin rash or hives •slurred speech •swollen face, eyelids, lips, tongue, or throat •unusual bleeding or bruising, pinpoint red spots on the skin •unusual tiredness or weakness •vision changes •yellowing of the skin or eyes Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •constipation or mild diarrhea •drowsiness •loss of appetite •mild nausea •upset stomach What should I watch for while taking Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide? (Back to top) See your prescriber or health care professional if pain continues or worsens while taking this product. Seek medical attention if new symptoms develop. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can increase the chance of drowsiness, dizziness, confusion, or liver problems while using this medicine. Avoid alcoholic drinks. If you drink 3 or more alcoholic beverages every day, check with your doctor before taking medicines which contain acetaminophen because of the possibility of liver damage. Do not smoke cigarettes. This may increase the chance of side effects from this medicine. If this medicine makes it difficult for you to sleep at night, take your last dose at least a few hours before bedtime. Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. Elderly patients over 60 years old may have a stronger reaction to this medicine and need smaller doses. This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See an eye doctor if the problem does not go away or is severe. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at room temperature between 15—30 degrees C (59—86 degrees F). Protect from heat and light. Throw away any unused medicine after the expiration date. Last Updated:09/07/2006 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.