Acetaminophen; Pseudoephedrine Oral Capsules or Tablets

What is this medication?

ACETAMINOPHEN; PSEUDOEPHEDRINE (a set a MEE noe fen; soo doe e FED rin) is a combination of a pain reliever and a decongestant. It is used to treat symptoms of the common cold and other sinus congestion with pain or fever.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): 666 Cold, Allerest, Dristan Cold, Genapap Sinus, Nexafed Sinus Pressure + Pain, Ornex, Sine-Off, Sine-Off Non-Drowsy, Sinus Relief, Sinutab, Sudafed Sinus and Cold, Sudafed Sinus Headache, Tavist, Tylenol Sinus, Vicks DayQuil Sinus

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

  • diabetes
  • glaucoma
  • heart disease
  • high blood pressure
  • if you often drink alcohol
  • kidney disease
  • liver disease
  • prostate trouble
  • taken a MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
  • thyroid disease
  • trouble passing urine
  • an unusual or allergic reaction to acetaminophen, pseudoephedrine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the package or prescription label. Do not chew, crush, or cut. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

  • bromocriptine
  • ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • stimulant medicines for attention disorders, weight loss, or to stay awake

This medicine may also interact with the following medications:

  • acetaminophen
  • alcohol
  • atropine
  • bretylium
  • caffeine
  • digoxin
  • isoniazid
  • linezolid
  • mecamylamine
  • medicines for blood pressure
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for enlarged prostate
  • medicines for sleep
  • other medicines for cold, cough or allergy
  • procarbazine
  • reserpine
  • St. John’s Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Check with your doctor if you have a fever for more than 3 days or if your congestion lasts more than 7 days. Get medical help if you have a sore throat for more than 2 days or if you have a sore throat with fever, headache, rash, swelling, nausea, or vomiting.

If you have difficulty sleeping at night while using this medicine, take your last dose a few hours before bedtime. If nervousness, dizziness, or sleeplessness occur, stop using and consult a health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • bloody or tarry stool
  • breathing problems
  • chest pain
  • confusion, dizzy, nervous
  • fever, chills, or sore throat
  • high blood pressure
  • trouble passing urine or change in the amount of urine
  • trouble sleeping
  • stomach cramps and pain
  • tremors
  • unusual bleeding or bruising, pinpoint red spots on the skin
  • unusually weak or tired
  • vomiting
  • yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • headache
  • loss of appetite
  • nausea
  • restless

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from heat and moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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