Acetaminophen, Caffeine, Phenyltoloxamine Citrate, Salicylamide Oral capsule

What is this medicine?

ACETAMINOPHEN; CAFFEINE; PHENYLTOLOXAMINE; SALICYLAMIDE (a set a MEE noe fen; KAF een; fen ill toe LOX a meen; sal i SILL a mide) is a pain reliever. It is used to relieve mild to moderate pain from headaches, the common cold, flu, or a sinus infection. It may also be used for pain from menstrual cramps, muscle or nerve pain, and arthritis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• asthma

• blood clotting problems

• glaucoma

• heart disease

• high blood pressure

• if you often drink alcohol

• kidney disease

• liver disease

• prostate problems

• stomach ulcer or other problem

• trouble passing urine

• an unusual reaction to acetaminophen, caffeine, phenyltoloxamine, salicylamide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you 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 may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methotrexate

• probenecid

This medicine may also interact with the following medications:

• acetaminophen

• acetazolamide

• alcohol

• antibiotics like ciprofloxacin, gatifloxacin, tetracycline

• aspirin and aspirin-like drugs

• caffeine

• green tea

• lithium

• medicines for allergies, congestion

• medicines for asthma or other breathing problems

• medicines for depression, anxiety, or psychotic disturbances

• medicines for seizures like fosphenytoin, phenobarbital, phenytoin

• medicines for sleep

• muscle relaxants

• varicella live vaccine

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

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. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

If this medicine makes it hard for you to sleep at night, take your last dose a few hours before bedtime.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion, excitable, nervous

• hearing problems

• fast, irregular heart beat

• feeling faint or lightheaded, falls

• high blood pressure

• problems with balance, talking, walking

• seizure

• tremor

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

• 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):

• dry mouth

• headache

• loss of appetite

• nausea, vomiting

• stomach upset

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep bottle closed tightly. Protect from light. Throw away any unused medicine after the expiration date.