Flextra DS

What is the most important information I should know about Flextra DS?

• Use caution when driving, operating machinery, or performing other hazardous activities. Flextra DS may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking Flextra DS. Alcohol may also cause damage to your liver when taken with acetaminophen.

What is Flextra DS?

• Acetaminophen is a pain reliever and a fever reducer.
• Phenyltoloxamine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Phenyltoloxamine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.
• Flextra DS is used to treat aches and pains, headache, fever, and congestion associated with the flu, colds, allergies, and hay fever.
• Flextra DS may also be used for purposes other than those listed in this medication guide.

Who should not take Flextra DS?

• Do not take 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. You may not be able to take acetaminophen.
• Do not take Flextra DS if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very serious drug interaction could occur, leading to serious side effects.
• Before taking this medication, tell your doctor if you have
  · liver disease;
  · kidney disease;
  · diabetes;
  · glaucoma;
  · difficulty urinating because of an enlarged prostate, a constricted bladder neck, or any other reason;
  · a stenosing peptic (stomach) ulcer;
  · high blood pressure or any type of heart disease; or
  · an overactive thyroid.
• You may not be able to take Flextra DS, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• It is not known whether Flextra DS will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.
• Flextra DS passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
• If you are over 60 years of age, you may be more likely to experience side effects from Flextra DS.
• Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Flextra DS?

• Take acetaminophen an phenyltoloxamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Never take more Flextra DS than is directed. 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 Flextra DS and never take more than 2 grams (2000 mg) per day.
• Consult your doctor if your symptoms do not improve within 10 days (or 5 days for children under 12 years of age) or if they get worse. Do not use this product to treat a fever for more than 3 days.
• Store Flextra DS at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of an Flextra DS overdose may include nausea, vomiting, diarrhea, abdominal pain, sweating, seizures, confusion, sedation, insomnia, tremor, hallucinations, and an irregular heartbeat.

What should I avoid while taking Flextra DS?

• Use caution when driving, operating machinery, or performing other hazardous activities. Flextra DS may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking Flextra DS. Alcohol may also cause damage to your liver when taken with acetaminophen.
• Flextra DS may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if Flextra DS is taken with any of these medications.

What are the possible side effects of Flextra DS?

• If you experience any of the following serious side effects, stop taking Flextra DS and seek emergency medical attention:
  · an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  · liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);
  · blood problems (easy or unusual bleeding or bruising); or
  · low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).
• Other, less serious side effects may be more likely to occur including:
  · dry eyes, nose, and mouth;
  · drowsiness or dizziness;
  · blurred vision;
  · difficulty urinating; or
  · excitation in children.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Flextra DS?

• Do not take Flextra DS if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very serious drug interaction could occur, leading to serious side effects.
• Urine glucose tests may produce false results while you are taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during therapy with Flextra DS.
• Do not take other over-the-counter cough, cold, allergy, diet, pain or sleep medicines while taking Flextra DS without first talking to your doctor. Other medications may also contain acetaminophen, phenyltoloxamine, or other similar drugs and you may accidentally take too much of these medicines.
• Flextra DS may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if Flextra DS is taken with any of these medications.
• Drugs other than those listed here may also interact with Flextra DS. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about Flextra DS written for health professionals that you may read.