Flextra DS - for pain, headache, and fever

Flextra DS®

Generic Name: acetaminophen and phenyltoloxamine
Brand Names: Acuflex, Apagesic, Duogesic, Flextra-DS, Genasec, Percogesic

Drug Uses
Flextra DS is an analgesic and antipyretic used to treat pain, headache, and fever. Flextra DS may also be used to relieve pain in certain kinds of arthritic conditions. Flextra DS is also used to treat other conditions as determined by your doctor.

How Taken
Take this medicine by mouth usually every 4 hours as needed or as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy. Do not exceed the recommended dosage or take this medicine for longer than recommended (e.g., 10 days for adults, 5 days for children, or 3 days if used for fever); persistent symptoms of pain or fever may be the sign of a more serious medical condition. Consult your doctor for additional information.

Warnings/Precautions
Tell your doctor your medical history, especially of: lung problems (e.g., bronchitis, emphysema), glaucoma, enlarged prostate or any allergies. This medicine may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Flextra DS may cause liver damage. Daily use of alcohol and Flextra DS may increase your risk for liver damage (symptoms include nausea, stomach pain, dark urine). Check with your doctor or pharmacist for more information. Caution is advised when using this product in children because they may be more sensitive to the effects of the drug (e.g., increased excitability). Tell your doctor if you are pregnant before using this medicine. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Missed Dose
Take the missed dose of Flextra DS prescription muscle relaxer as soon as you remember. However, if it is almost time for your next dose of Flextra DS prescription muscle relaxer, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of Flextra DS prescription muscle relaxer.

Possible Side Effects
Drowsiness or nausea may occur. If either of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: skin redness, swelling, persistent fever, stomach pain, yellowing eyes and skin, dark urine, unusual weakness. If you notice other effects not listed above, contact your doctor or pharmacist.

Storage
Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.

Overdose
The following symptoms indicate an overdose, get medical help immediately: difficulty breathing, extreme nervousness or restlessness, flushed skin, hallucination, racing or irregular heartbeat, seizure, shortness of breath, tiredness (extreme), unstable temperature, unusual muscle stiffness, vomiting (in combination with these other symptoms).

More Information
DO NOT DRIVE, OPERATE MACHINERY OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Flextra DS or other pain relievers/fever reducers. Flextra DS may cause liver damage. Alcohol use combined with this medicine may increase your risk for liver damage.

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.

Acetaminophen and phenyltoloxamine is used to treat aches and pains, headache, fever, and congestion associated with the flu, colds, allergies, and hay fever.

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

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen and phenyltoloxamine 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 acetaminophen and phenyltoloxamine. Alcohol may also cause damage to your liver when taken with acetaminophen.

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 acetaminophen and phenyltoloxamine 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 acetaminophen and phenyltoloxamine, 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 acetaminophen and phenyltoloxamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Acetaminophen and phenyltoloxamine 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 acetaminophen and phenyltoloxamine. 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.

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 acetaminophen and phenyltoloxamine 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 acetaminophen and phenyltoloxamine 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.