Acetaminophen, dextromethorphan, and diphenhydramine

Acetaminophen is a pain reliever and fever reducer.

Diphenhydramine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Acetaminophen, diphenhydramine, and dextromethorphan is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, and sore throat caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, diphenhydramine, and dextromethorphan may also be used for purposes not listed in this medication guide.

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.

Do not take more of this medication 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 this medicine 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.

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 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.

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

• severe headache, seizure (convulsions);

• fast, pounding, or uneven heartbeats;

• confusion, hallucinations, severe dizziness or drowsiness, slow or shallow breathing;

• tremor, restless muscle movements;

• little or no urinating;

• flu symptoms, easy bruising, unusual bleeding, pale skin, weakness, 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).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• headache, sleep problems (insomnia);

• upset stomach, diarrhea or 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.

Usual Adult Dose for Cold Symptoms:

Acetaminophen/dextromethorphan/diphenhydramine 325 mg-10 mg-12.5 mg/5 mL:
10 mL orally every 4 to 6 hours not to exceed 6 doses daily.

Usual Adult Dose for Influenza:

Acetaminophen/dextromethorphan/diphenhydramine 325 mg-10 mg-12.5 mg/5 mL:
10 mL orally every 4 to 6 hours not to exceed 6 doses daily.

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen/dextromethorphan/diphenhydramine 325 mg-10 mg-12.5 mg/5 mL:
>=12 yrs: 10 mL orally every 4 to 6 hours not to exceed 6 doses daily.
>=6 yrs to =12 yrs: 10 mL orally every 4 to 6 hours not to exceed 6 doses daily.
>=6 yrs to

Applies to acetaminophen / dextromethorphan / diphenhydramine: oral liquid

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

There are no data on the excretion of acetaminophen/dextromethorphan/diphenhydramine into human milk. Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of dextromethorphan into human milk. Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.