Dologesic

Acetaminophen is a medicine that helps relieve pain and reduce fever.

Phenyltoloxamine is an antihistamine that helps lessen the effects of histamine in the body. Histamine can cause symptoms like sneezing, itching, watery eyes, and a runny nose.

Dologesic is a combination medicine used to treat fever, headache, menstrual pain, and other minor aches and pains. Dologesic also helps with itchy or watery eyes, and pain or fever caused by the common cold or seasonal allergies.

Dologesic may also be used for other reasons not mentioned in this medication guide.

Do not take more of Dologesic than is recommended. An overdose of acetaminophen can harm your liver or cause death.

Use exactly as directed on the label or as prescribed by your doctor. This medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with the dosing syringe provided or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than recommended. Stop taking the medicine and call your doctor if:

• you still have a fever after 3 days of use;
• you still have pain after 10 days;
• your symptoms get worse; or
• you have any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

Do not take more than your recommended dose. An acetaminophen overdose can damage your liver or cause death. Call your doctor immediately if you experience nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Dologesic and call your doctor right away if you notice skin redness or a rash that spreads and causes blistering and peeling.

You should not take this medication if you are allergic to acetaminophen or phenyltoloxamine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• asthma or COPD, emphysema, or other breathing problems;
• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;
• enlarged prostate or urination problems;
• glaucoma; or
• if you also take warfarin (Coumadin, Jantoven).

Dologesic should not be given to a child younger than 12 years old without medical advice.

It is not known whether this medicine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

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.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could happen even if you have taken acetaminophen before and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

This medication may cause serious side effects. Stop using this medication and call your doctor at once if you have:

• confusion, hallucinations, unusual thoughts or behavior;
• little or no urinating; or
• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Dologesic may include:

• dizziness, drowsiness;
• feeling restless or excited (especially in children);
• constipation;
• blurred vision; or
• dry mouth, nose, or throat.

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.

Since this medicine is taken as needed, you might not follow a dosing schedule. If you are on a schedule, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to compensate for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of phenyltoloxamine.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Dologesic may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can make these effects worse. Ask your doctor before taking Dologesic with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.