Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Name: Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to acetaminophen, dextromethorphan, doxylamine, or pseudoephedrine.

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, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

  • a cough with mucus;

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

  • heart disease, high blood pressure;

  • glaucoma;

  • diabetes;

  • a thyroid disorder;

  • enlarged prostate with urination problems; or

  • if you take a blood thinner such as warfarin (Coumadin, Jantoven).

It is not known whether this medication will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

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

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine dosing information

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.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Liver Dose Adjustments

Data not available

Precautions

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.

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