acetaminophen and phenylephrine

Generic Name: acetaminophen and phenylephrine (a SEET a MIN oh fen and FEN il EFF rin)Brand names: Alka-Seltzer Plus Cold and Sinus, Excedrin Sinus Headache Caplet, Mapap Sinus Congestion and Pain, Robitussin Nasal Relief, Sinus Congestion and Pain Daytime Cool Ice, Sinus Pain & Pressure, Sudafed PE Sinus Headache, Theraflu Daytime Severe Cold, Tylenol Sinus Congestion Daytime, Congespirin Aspirin Free, Mapap Sinus PE, Non-Pseudo Sinus Pain & Pressure, Sinus Pain & Pressure

 

What is acetaminophen and phenylephrine?

Acetaminophen is a pain reliever and a fever reducer.

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

The combination of acetaminophen and phenylephrine is used to treat headache, fever, body aches, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

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

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do 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 acetaminophen and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other pain, cold, allergy, 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.

What should I discuss with my healthcare provider before taking acetaminophen and phenylephrine?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do 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. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

  • liver disease, cirrhosis, or a history of alcoholism-

  • diabetes-

  • glaucoma-

  • epilepsy or other seizure disorder-

  • enlarged prostate or urination problems- or

  • pheochromocytoma (an adrenal gland tumor).

It is not known whether acetaminophen and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take acetaminophen and phenylephrine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This 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. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. 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 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking acetaminophen and phenylephrine?

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

Acetaminophen and phenylephrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives- difficult breathing- swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
  • chest pain, fast, slow, or uneven heart rate-

  • confusion, hallucinations-

  • tremor, seizure (convulsions)-

  • urinating less than usual or not at all-

  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes)- or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

  • dizziness, weakness-

  • mild headache-

  • mild nausea, diarrhea, upset stomach-

  • runny nose-

  • feeling nervous, restless, or anxious- or

  • sleep problems (insomnia).

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.

Acetaminophen and phenylephrine Dosing Information

Usual Adult Dose for Nasal Congestion:

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:2 tablets fully dissolved in 4 ounces of water every 4 hours.Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 650 mg - phenylephrine 10 mg oral powder:Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Usual Adult Dose for Sinus Symptoms:

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:2 tablets fully dissolved in 4 ounces of water every 4 hours.Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 650 mg - phenylephrine 10 mg oral powder:Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Usual Adult Dose for Headache:

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:2 tablets fully dissolved in 4 ounces of water every 4 hours.Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 650 mg - phenylephrine 10 mg oral powder:Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Usual Pediatric Dose for Nasal Congestion:

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:12 years to 18 years: 2 tablets fully dissolved in 4 ounces of water every 4 hours.Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:12 years or older: 2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:12 years or older: 2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:12 years: years or older: 2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 650 mg - phenylephrine 10 mg oral powder:12 yrs or older: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.Dose all other formulations based on the acetaminophen component:2 to 3 years: 160 mg/dose.4 to 5 years: 240 mg/dose.6 to 8 years: 320 mg/dose .9 to 10 years: 400 mg/dose.11 to 12 years: 480 mg/dose.13 years or older: 325 to 650 mg/dose.Maximum: 5 doses/day.

Usual Pediatric Dose for Sinus Symptoms:

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:12 years to 18 years: 2 tablets fully dissolved in 4 ounces of water every 4 hours.Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:12 years or older: 2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:12 years or older: 2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:12 years: years or older: 2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 650 mg - phenylephrine 10 mg oral powder:12 yrs or older: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.Dose all other formulations based on the acetaminophen component:2 to 3 years: 160 mg/dose.4 to 5 years: 240 mg/dose.6 to 8 years: 320 mg/dose .9 to 10 years: 400 mg/dose.11 to 12 years: 480 mg/dose.13 years or older: 325 to 650 mg/dose.Maximum: 5 doses/day.

Usual Pediatric Dose for Headache:

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:12 years to 18 years: 2 tablets fully dissolved in 4 ounces of water every 4 hours.Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:12 years or older: 2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:12 years or older: 2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:12 years: years or older: 2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.Acetaminophen 650 mg - phenylephrine 10 mg oral powder:12 yrs or older: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.Dose all other formulations based on the acetaminophen component:2 to 3 years: 160 mg/dose.4 to 5 years: 240 mg/dose.6 to 8 years: 320 mg/dose .9 to 10 years: 400 mg/dose.11 to 12 years: 480 mg/dose.13 years or older: 325 to 650 mg/dose.Maximum: 5 doses/day.

What other drugs will affect acetaminophen and phenylephrine?

Ask a doctor or pharmacist if it is safe for you to take acetaminophen and phenylephrine if you are also using any of the following drugs:

  • leflunomide (Arava)-

  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine-

  • birth control pills or hormone replacement therapy-

  • blood pressure medication-

  • cancer medicine-

  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others-

  • gout or arthritis medications (including gold injections)-

  • HIV/AIDS medication-

  • medicines to treat psychiatric disorders-

  • an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others- or

  • seizure medication.

This list is not complete and other drugs may interact with acetaminophen and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about acetaminophen and phenylephrine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.