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May 24, 2013
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Medications and Drugs

Brand Names: Flextra Plus

Generic Name: acetaminophen, caffeine, and phenyltoloxamine (Pronunciation: a SEET a MIN o fen KAF een, FEN il toe LOX a meen)

What is acetaminophen, caffeine, and phenyltoloxamine (Flextra Plus)?

Acetaminophen is a pain reliever and fever reducer.

Caffeine is a stimulant.

Phenyltoloxamine is an antihistamine.

The combination of 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 other purposes not listed in this medication guide.

What are the possible side effects of acetaminophen, caffeine, and phenyltoloxamine (Flextra Plus)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeat;
  • easy bruising, unusual bleeding or weakness;
  • feeling light-headed, fainting;
  • urinating less than usual;
  • increased thirst and urination;
  • muscle weakness, lack of coordination; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • feeling nervous or irritable;
  • sleep problems (insomnia);
  • dizziness or drowsiness;
  • dry mouth, nose or throat;
  • mild itching or skin rash;
  • upset stomach, nausea, cramps, or diarrhea;
  • trouble concentrating; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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 cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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