Acetaminophen, dextromethorphan, and doxylamine

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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).

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.

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

This medication may cause blurred vision and may 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 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).

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 Cough:

Acetaminophen/dextromethorphan/doxylamine 1000 mg-30 mg-12.5 mg/30 mL oral liquid:
30 mL orally every 6 hours not to exceed 120 mL daily.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg- 6.25 mg oral capsule:
2 capsules every 6 hours as needed not to exceed 8 capsules/day.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg-6.25 mg/15 mL oral liquid:
30 mL orally every 6 hours not to exceed 120 mL daily.

Usual Adult Dose for Pain:

Acetaminophen/dextromethorphan/doxylamine 1000 mg-30 mg-12.5 mg/30 mL oral liquid:
30 mL orally every 6 hours not to exceed 120 mL daily.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg- 6.25 mg oral capsule:
2 capsules every 6 hours as needed not to exceed 8 capsules/day.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg-6.25 mg/15 mL oral liquid:
30 mL orally every 6 hours not to exceed 120 mL daily.

Usual Pediatric Dose for Cough:

Acetaminophen/dextromethorphan /doxylamine 1000 mg- 30 mg 12.5 mg/30 mL oral liquid:
12 years or older: 30 mL orally every 6 hours not to exceed 120 mL daily.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg- 6.25 mg oral capsule:
12 years or older: 2 capsules every 6 hours as needed not to exceed 8 capsules/day.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg-6.25 mg/15 mL oral liquid:
12 years or older: 30 mL orally every 6 hours not to exceed 120 mL daily.

Usual Pediatric Dose for Pain:

Acetaminophen/dextromethorphan /doxylamine 1000 mg- 30 mg 12.5 mg/30 mL oral liquid:
12 years or older: 30 mL orally every 6 hours not to exceed 120 mL daily.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg- 6.25 mg oral capsule:
12 years or older: 2 capsules every 6 hours as needed not to exceed 8 capsules/day.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg-6.25 mg/15 mL oral liquid:
12 years or older: 30 mL orally every 6 hours not to exceed 120 mL daily.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of acetaminophen / dextromethorphan / doxylamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Acetaminophen/dextromethorphan /doxylamine 1000 mg- 30 mg 12.5 mg/30 mL oral liquid:
12 years or older: 30 mL orally every 6 hours not to exceed 120 mL daily.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg- 6.25 mg oral capsule:
12 years or older: 2 capsules every 6 hours as needed not to exceed 8 capsules/day.

Acetaminophen/dextromethorphan/doxylamine 325 mg-15 mg-6.25 mg/15 mL oral liquid:
12 years or older: 30 mL orally every 6 hours not to exceed 120 mL daily.