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

Do not use this medication if you are allergic to acetaminophen (Tylenol), caffeine, or phenyltoloxamine.

Do not use this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to use acetaminophen.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take this medication:

• 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.

FDA pregnancy category C. It is not known whether acetaminophen, caffeine, and phenyltoloxamine is harmful to an unborn baby. Before taking this medication, 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.

How should I take acetaminophen, caffeine, and phenyltoloxamine (Flextra Plus)?

Take this medication exactly as it was prescribed for you. Do not take it in larger doses or take it for longer than 10 days unless your doctor has told you to. Follow the directions on your prescription label.

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.

Store the medication at room temperature away from moisture and heat.

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