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What is the most important information I should know about acetaminophen, caffeine, and phenyltoloxamine?

Do not use this medication for longer than 10 days unless your doctor has told you to.

Do not take more than six (6) capsules in a 24-hour period. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day. Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen is contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen.

What is acetaminophen, caffeine, and phenyltoloxamine?

Acetaminophen is a non-aspirin pain reliever. Caffeine is a stimulant that helps restore mental alertness. Phenyltoloxamine is an antihistamine that blocks the chemical in your body that produces allergy symptoms such as sneezing and runny nose.

Acetaminophen, caffeine, and phenyltoloxamine is used to treat mild to moderate pain and discomfort caused by headache, the common cold, muscle or joint pain, nerve pain, sinus pain, tooth pain, menstrual pain, or minor aches and pains of arthritis.

Acetaminophen, caffeine, and phenyltoloxamine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before taking acetaminophen, caffeine, and phenyltoloxamine?

Before using this medication, tell your doctor if you have:

• asthma;

• an allergy to aspirin;

• kidney disease;

• liver disease;

• a stomach disorder such as an ulcer or obstruction;

• urination or prostate problems; or

• a history of blood clots.

If you have any of these conditions, you may not be able to use this medication or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen, caffeine, and phenyltoloxamine.

Do not give this medication to a child younger than 12 years old.