Acetaminophen/ Phenyltoloxamine

Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, backache, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis, and to reduce fever. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Phenyltoloxamine is an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.

• you are allergic to any ingredient in Acetaminophen/Phenyltoloxamine
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Acetaminophen/Phenyltoloxamine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bleeding problems, blood vessel problems in the brain, a blockage of the stomach or bowel, a blockage of the bladder, or difficulty urinating
• if you have lung problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), an enlarged prostate, glaucoma, kidney problems, or liver problems

Some MEDICINES MAY INTERACT with Acetaminophen/Phenyltoloxamine . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Isoniazid, monoamine oxidase (MAO) inhibitors (eg, phenelzine), or sodium oxybate (GHB) because the risk of side effects may be increased
• Anticoagulants (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Phenyltoloxamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Use Acetaminophen/Phenyltoloxamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Acetaminophen/Phenyltoloxamine may be taken with or without food.
• If you miss a dose of Acetaminophen/Phenyltoloxamine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Phenyltoloxamine .

• Acetaminophen/Phenyltoloxamine may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Phenyltoloxamine . Using Acetaminophen/Phenyltoloxamine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Acetaminophen/Phenyltoloxamine contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.
• Avoid taking medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Acetaminophen/Phenyltoloxamine . Acetaminophen/Phenyltoloxamine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not exceed the recommended dosage or take Acetaminophen/Phenyltoloxamine for longer than prescribed without checking with your doctor.
• If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Acetaminophen/Phenyltoloxamine or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Acetaminophen/Phenyltoloxamine may increase your risk for liver damage.
• If you are taking Acetaminophen/Phenyltoloxamine for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.
• Before you have any medical or dental treatments or surgery, tell the doctor or dentist that you are taking Acetaminophen/Phenyltoloxamine .
• Caution is advised when using Acetaminophen/Phenyltoloxamine in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: It is unknown if Acetaminophen/Phenyltoloxamine can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Acetaminophen/Phenyltoloxamine during pregnancy. Acetaminophen/Phenyltoloxamine is excreted in breast milk. Do not breast-feed while taking Acetaminophen/Phenyltoloxamine .

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine or pale stools; decreased urination; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects atIf OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control centeror emergency room immediately. Symptoms may include abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.

Store Acetaminophen/Phenyltoloxamine at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Phenyltoloxamine out of the reach of children and away from pets.

• If you have any questions about Acetaminophen/Phenyltoloxamine , please talk with your doctor, pharmacist, or other health care provider.
• Acetaminophen/Phenyltoloxamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acetaminophen/Phenyltoloxamine . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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