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What are Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine extended-release tablets?

ACETAMINOPHEN; CHLORPHENIRAMINE; PHENYLEPHRINE; PHENYLTOLOXAMINE (Norel® SR) treats symptoms such as headache, pain, congestion, runny nose, and sneezing which may occur with allergies. Acetaminophen and phenyltoloxamine are used to relieve pain. Chlorpheniramine is an antihistamine that helps stop a runny nose and sneezing. Phenylephrine is a decongestant that helps with nasal stuffiness.

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

They need to know if you have any of these conditions:
• anemia or blood disease
• asthma
• diabetes
• difficulty passing urine or other bladder problems
• emphysema, bronchitis, or other lung disease
• enlarged prostate
• glaucoma
• heart disease including angina, history of heart attack, blockage in heart vessels, heart failure
• high blood pressure
• history of stroke or mini-strokes (TIAs)
• problems with immune system
• irregular heart beat
• kidney disease
• liver disease
• poor circulation (peripheral vascular disease)
• stomach ulcers or bleeding
• over active thyroid
• an unusual reaction to Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Take this medicine by mouth. Follow the directions on the prescription label. Do not crush or chew extended-release tablets. Scored tablets may be split in half for taking smaller doses. Swallow dose with plenty of water. This medicine may be taken with food or milk if upset stomach occurs. Do not take it more often than directed. Do not share this medicine with anyone.

Patients over 60 years old may have a stronger reaction to this medicine. Smaller doses may be needed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine?

• amphetamine, cocaine, or other stimulant drugs
• antacids
• aspirin or similar medicines
• atomoxetine
• atropine
• bretylium
• busulfan
• caffeine
• carbamazepine or oxcarbazepine
• cholestyramine
• cyclopropane
• digoxin or similar medicines
• doxercalciferol
• efavirenz
• ethotoin
• exenatide
• furazolidone
• imatinib
• isoniazid
• lamotrigine
• linezolid
• mecamylamine
• medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)
• medicines for depression or other mental problems, especially tricyclic antidepressants (e.g., Elavil®, Pamelor®)
• medicines for chest pain, heart disease, high blood pressure, or heart rhythm problems
• medicines for diabetes
• some medicines used for migraines (ergotamine, dihydroergotamine, ergonovine, methysergide)
• medicines for mental problems and psychotic disturbances
• medicines for movement abnormalities such as Parkinson's disease
• medicines for weight loss (including some herbal products, ephedrine, dextroamphetamine)
• midodrine
• nevirapine
• phenytoin or fosphenytoin
• prilocaine
• procarbazine
• rifampin
• rifabutin
• St. John's wort
• theophylline
• thyroid hormones
• warfarin
• zidovudine

Because this product can cause drowsiness, other medicines that also cause drowsiness may increase this effect. Some medicines that cause drowsiness are:
• alcohol and alcohol-containing medicines
• barbiturate medicines for inducing sleep or treating seizures (convulsions)
• medicines for anxiety or sleeping problems, such as diazepam or temazepam
• other medicines for allergies, such as antihistamines or decongestants
• medicines for motion sickness
• muscle relaxers
• prescription pain medicines

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine?

See your prescriber or health care professional if fever or pain continue or worsen while taking this product. Seek medical attention if new symptoms develop.

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. Alcohol can increase the chance of drowsiness, dizziness, confusion, or liver problems while using this medicine. Avoid alcoholic drinks. If you drink 3 or more alcoholic beverages every day, check with your doctor before taking medicines which contain acetaminophen because of the possibility of liver damage.

Do not smoke cigarettes. This may increase the chance of side effects from this medicine.

If this medicine makes it difficult for you to sleep at night, take your last dose at least a few hours before bedtime.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

Elderly patients over 60 years old may have a stronger reaction to this medicine and need smaller doses.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See an eye doctor if the problem does not go away or is severe.

What side effects may I notice from receiving Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• agitation, nervousness, excitability, not able to sleep (these are more likely in children)
• bloody stools
• chest pain
• confusion
• difficulty breathing or wheezing
• difficulty urinating
• headache, especially if severe or gets worse
• high blood pressure
• irregular heart beat
• nausea and vomiting
• seizures
• skin rash or hives
• slurred speech
• unusual bleeding or bruising, pinpoint red spots on the skin
• unusual tiredness or weakness
• vision changes
• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• constipation
• loss of appetite
• nausea

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

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

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.