Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Name: Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

What is the most important information I should know about this medicine?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or 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.

What are some side effects that I need to call my doctor about right away?

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.

Usual Adult Dose for Cold Symptoms

acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.

Usual Pediatric Dose for Cold Symptoms

acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule:
12 yrs and older: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.

Renal Dose Adjustments

Data not available

Dialysis

Data not available

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