Acetaminophen and pseudoephedrine

Name: Acetaminophen and pseudoephedrine

What is acetaminophen and pseudoephedrine?

Acetaminophen is a pain reliever and a fever reducer.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Acetaminophen and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen and pseudoephedrine?

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 this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

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

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.

How should I take acetaminophen and pseudoephedrine?

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

The chewable tablet must be chewed before you swallow it.

Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

What should I avoid while taking acetaminophen and pseudoephedrine?

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

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.

Acetaminophen and pseudoephedrine dosing information

Usual Adult Dose for Sinus Symptoms:

2 tablets or capsules (325 mg-30 mg or 500 mg-30 mg strength) orally every 4 to 6 hours as needed, no more than four times a day.

Usual Pediatric Dose for Fever:

Infant drops (80 mg-7.5 mg/0.8 mL):
2 to 3 years or 24 to 35 lbs: 1.6 mL (2 droppersful) orally every 4 to 6 hours as needed, no more than four times a day.

Children's liquid (160 mg-15 mg/5 mL):
2 to 3 years or 24 to 35 lbs: 5 mL (1 teaspoonful) orally every 4 to 6 hours as needed, no more than four times a day.
4 to 5 years or 36 to 47 lbs: 7.5 mL (1 1/2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
6 to 8 years or 48 to 59 lbs: 10 mL (2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
9 to 10 years or 60 to 71 lbs: 12.5 mL (2 1/2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
11 years or 72 to 95 lbs: 15 mL (3 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.

Children's Chewable tablets (160 mg-15 mg):
2 to 5 years: 1 tablets orally every 4 to 6 hours as needed, no more than four times a day.
6 to 11 years: 2 tablets orally every 4 to 6 hours as needed, no more than four times a day.

Usual Pediatric Dose for Sinus Symptoms:

Infant drops (80 mg-7.5 mg/0.8 mL):
2 to 3 years or 24 to 35 lbs: 1.6 mL (2 droppersful) orally every 4 to 6 hours as needed, no more than four times a day.

Children's liquid (160 mg-15 mg/5 mL):
2 to 3 years or 24 to 35 lbs: 5 mL (1 teaspoonful) orally every 4 to 6 hours as needed, no more than four times a day.
4 to 5 years or 36 to 47 lbs: 7.5 mL (1 1/2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
6 to 8 years or 48 to 59 lbs: 10 mL (2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
9 to 10 years or 60 to 71 lbs: 12.5 mL (2 1/2 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.
11 years or 72 to 95 lbs: 15 mL (3 teaspoonsful) orally every 4 to 6 hours as needed, no more than four times a day.

Children's Chewable tablets (160 mg-15 mg):
2 to 5 years: 1 tablets orally every 4 to 6 hours as needed, no more than four times a day.
6 to 11 years: 2 tablets orally every 4 to 6 hours as needed, no more than four times a day.

What are some things I need to know or do while I take Acetaminophen and Pseudoephedrine?

  • Tell all of your health care providers that you take acetaminophen and pseudoephedrine. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not use this medicine for longer than you were told by your doctor.
  • Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
  • This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
  • Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
  • Talk with your doctor before you drink alcohol.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with acetaminophen and pseudoephedrine.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Different brands of acetaminophen and pseudoephedrine may have different doses for children. Talk with the doctor before giving this medicine to a child.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using acetaminophen and pseudoephedrine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Dosing Pediatric

Sinus congestion/headache: Oral: Children ≥12 years of age and Adolescents: Refer to adult dosing.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution in patients with hepatic impairment or active liver disease.

Adverse Reactions

See individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, anxiety, or insomnia. Have patient report immediately to prescriber signs of hepatic impairment, urinary retention, oliguria, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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