Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Phenyltoloxamine Citrate Oral tablet, extended-release

What is this medicine?

ACETAMINOPHEN; CHLORPHENIRAMINE; PHENYLEPHRINE; PHENYLTOLOXAMINE (a set a MEE noe fen; klor fen IR a meen; fen il EF rin; fen ill toe LOX a meen) is a combination of a pain reliever, a decongestant, and two antihistamines. It is used to treat the symptoms of allergies like congestion, headache, runny nose, and sneezing. This medicine will not treat an infection.

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

What should I tell my health care provider before I take this medicine?

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

  • asthma

  • diabetes

  • glaucoma

  • heart disease

  • high blood pressure

  • if you often drink alcohol

  • kidney disease

  • liver disease

  • mental disorders like psychosis

  • thyroid disease

  • trouble passing urine

  • an unusual or allergic reaction to acetaminophen, chlorpheniramine, phenylephrine, phenyltoloxamine, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. If it upsets your stomach, take it with food or milk. Tablets may be broken in half. Do not chew or crush this medicine. 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 old 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 medicine?

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

  • alcohol

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

  • acetaminophen

  • aspirin and aspirin-like medicines

  • barbiturates like phenobarbital

  • digoxin

  • diuretics

  • mecamylamine

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for sleep

  • muscle relaxers

  • narcotic pain medicines

  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

  • other medicines for cold, cough or allergy

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

  • some heart medicines like atenolol, propranolol

  • stimulant medicines like dextroamphetamine

  • St. John's Wort

  • theophylline

  • warfarin

  • zidovudine

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 medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

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 medicine?

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

  • changes in vision

  • chest pain, tightness

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • unusually weak or tired

  • yellowing of 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):

  • drowsiness

  • dry eyes, mouth

  • loss of appetite

  • stomach upset

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.