Percogesic Extra Strength contains a combination of acetaminophen and diphenhydramine. Acetaminophen is a pain reliever and a fever reducer. Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Percogesic Extra Strength is used to treat headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual and menstrual cramps.

Percogesic Extra Strength is also used for the temporary relief of runny nose, sneezing, itchy nose and throat.

Do not take more Percogesic Extra Strength than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

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 taking acetaminophen.

Use Percogesic Extra Strength exactly as directed on the label, or as prescribed by your doctor. Do not take Percogesic Extra Strength for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not take more Percogesic Extra Strength than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Stop taking Percogesic Extra Strength and call your doctor if you still have a fever after 3 days, or you still have pain after 10 days (or 5 days if treating a child). Also call your doctor if your symptoms get worse, or if you have any redness or swelling.

If you need surgery or medical tests, tell the doctor ahead of time if you have taken Percogesic Extra Strength within the past few days.

Store Percogesic Extra Strength at room temperature away from moisture and heat.

Active ingredients in each caplet - acetaminophen 500 mg and diphenhydramine HCl 12.5 mg.

Adults and children 12 years of age and older: take 2 caplets every 6 hours. Maximum daily dose is 6 caplets.
Children under 12 years of age: ask your doctor.

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

You should not use Percogesic Extra Strength if you are allergic to acetaminophen and diphenhydramine, or if you have:

• severe constipation, blockage in your stomach or intestines;

• untreated or uncontrolled diseases - glaucoma, asthma, heart disease, overactive thyroid; or

• if you are unable to urinate.

Ask a doctor or pharmacist before taking Percogesic Extra Strength if you have any medical condition, especially:

• kidney disease;

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

• an enlarged prostate, problems with urination;

• a history of alcoholism; or

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

It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Do not use Percogesic Extra Strength without a doctor's advice if you are pregnant.

Acetaminophen and diphenhydramine can pass into breast milk and may harm a nursing baby. Antihistamines may slow breast milk production. Do not use Percogesic Extra Strength without a doctor's advice if you are breast-feeding a baby.

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

Since Percogesic Extra 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.

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 taking acetaminophen.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction to Percogesic Extra Strength: 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 Percogesic Extra 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.

Stop using the medicine and call your doctor at once if you have:

• fast, pounding, or uneven heartbeats;

• severe dizziness or drowsiness, slow or shallow breathing;

• tremor, restless muscle movements;

• little or no urinating;

• flu symptoms, easy bruising, unusual bleeding, pale skin, feeling light-headed; or

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

Common Percogesic Extra Strength side effects may include:

• constipation;

• dry eyes, blurred vision, dry mouth or nose;

• mild dizziness or drowsiness, trouble concentrating;

• feeling restless or excited (especially in children); or

• mild skin rash.

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.

Other drugs may interact with acetaminophen and diphenhydramine, 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.