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Acetaminophen, Diphenhydramine, and Phenylephrine (a seet a MIN oh fen, dye fen HYE dra meen, & fen il EF rin)

Adult Medication

Brand Names: U.S.

Benadryl® Allergy and Cold [OTC]; Benadryl® Allergy and Sinus Headache [OTC]; Benadry® Maximum Strength Severe Allergy and Sinus Headache [OTC]; Cold Control PE [OTC]; Mucinex Fast-Max Night Time Cold & Flu [OTC]; Mucinex Sinus-Max Night Time Congestion & Cough [OTC]; One Tab™ Allergy & Sinus [OTC]; One Tab™ Cold & Flu [OTC]; Robitussin® Peak Cold Nighttime Multi-Symptom Cold [OTC]; Sudafed PE® Nighttime Cold [OTC]; Sudafed PE® Severe Cold [OTC]; Theraflu® Nighttime Severe Cold & Cough [OTC]; Theraflu® Sugar-Free Nighttime Severe Cold & Cough [OTC]; Theraflu® Warming Relief™ Flu & Sore Throat [OTC]; Theraflu® Warming Relief™ Nighttime Severe Cold & Cough [OTC]; Tylenol® Allergy Multi-Symptom Nighttime [OTC]; Tylenol® Children’s Plus Cold and Allergy [OTC]

What is this drug used for?

  • It is used to treat nose stuffiness.
  • It is used to ease allergy signs.
  • It is used to ease pain and fever.

What do I need to tell my doctor BEFORE I take this drug?

  • If you have an allergy to acetaminophen, diphenhydramine, phenylephrine, or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure. Talk with your doctor.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

All products:

  • Tell dentists, surgeons, and other doctors that you use this drug.
  • 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 take this drug for longer than you were told by your doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Avoid beer, wine, or mixed drinks.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • Do not use with other products that have diphenhydramine.
  • Avoid other sources of acetaminophen. An overdose may cause problems.
  • This drug 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.
  • This drug may affect certain lab tests. Be sure your doctor and lab workers know you take this drug.
  • Use with care in children. Talk with the doctor.
  • Different brands of this drug may have different doses for children. Talk with the doctor before giving this drug to a child.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Powder:

  • If you have PKU, talk with your doctor. Some products have phenylalanine.

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.

What are some other side effects of this drug?

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:
  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.
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 your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.

All products:

  • Take with or without food. Take with food if it causes an upset stomach.

Liquid:

  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, get an oral syringe, a dropper, a spoon, or a cup (only for older children) from your pharmacist.

Liquid (suspension):

  • Shake well before use.

Powder:

  • Melt 1 packet in hot water. Sip while hot.
  • If using a microwave, melt 1 packet in cool water. Microwave until hot. Do not overheat. Stir before and after heating.

What do I do if I miss a dose?

  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.

How do I store and/or throw out this drug?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

Copyright © 2014 Clinical Drug Information, LLC and Lexi-Comp, Inc.