Acetaminophen is a pain reliever and fever reducer.

Pamabrom is a diuretic (water pill).

Pyrilamine is an antihistamine that reduces the effects of natural chemical histamine in the body.

Midol PMS Maximum Strength is a combination medicine used to treat the symptoms of premenstrual syndrome (PMS), such as tension, bloating, water weight gain, headache, muscle pain, cramps, and irritability.

Midol PMS Maximum Strength may also be used for purposes not listed in this medication guide.

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

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.

In rare cases, acetaminophen may cause a severe skin 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.

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. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Stop taking this medication and call your doctor if:

• you have a fever lasting longer than 3 days;

• you have pain lasting longer than 10 days; or

• your symptoms get worse, or if you have any new symptoms.

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.

You should not use Midol PMS Maximum Strength if you are allergic to acetaminophen (Tylenol), pamabrom, or pyrilamine.

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

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

• kidney disease;

• glaucoma;

• enlarged prostate or urination problems;

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• if you take a blood thinner (warfarin, Coumadin); or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether Midol PMS Maximum Strength will harm an unborn baby. Do not use this medicine without telling your doctor if you are pregnant or plan to become pregnant while using the medicine.

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

Do not give this medication to a child younger than 12 years old without the advice of a doctor. Children younger than 3 years old should not take Midol PMS Maximum Strength.

Since Midol PMS Maximum Strength is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Never take more than 8 tablets in one 24-hour period.

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.

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.

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

Midol PMS Maximum Strength 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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 occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Midol PMS Maximum Strength 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 medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• any redness or swelling;

• little or no urination; or

• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Midol PMS Maximum Strength may include:

• dizziness, drowsiness;

• dry mouth, nose, or throat;

• constipation;

• blurred vision; or

• feeling restless or excited (especially in children).

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.

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

Other drugs may interact with acetaminophen, pamabrom, and pyrilamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.