How does this medication work? What will it do for me?

This combination product contains three medications: codeine, triprolidine, and pseudoephedrine.

Codeine belongs to the group of medications called narcotic analgesics and cough suppressants.

Triprolidine belongs to the group of medications called antihistamines, and helps to relieve sneezing and runny nose.

Pseudoephedrine belongs to the group of medications called nasal decongestants, and reduces nasal congestion.

Codeine - triprolidine - pseudoephedrine is used to treat coughs related to inflamed tissues in the nose and throat. It works by reducing inflammation in the nose and throat tissues and decreasing cough.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Tablets

Each white to off-white, biconvex tablet, code number "WELLCOME P4B" on same side as score mark, contains triprolidine HCl 4 mg, pseudoephedrine HCl 60 mg, and codeine phosphate 20 mg. Nonmedicinal ingredients: cornstarch, starch, lactose, gelatin, magnesium stearate, and yellow colourant. Each tablet is equivalent to 10 mL of syrup. If the tablet is broken in half, it reveals a yellow core. This medication does not contain tartrazine.

Syrup

Each 5 mL of clear, dark red syrupy liquid contains triprolidine HCl 2 mg, pseudoephedrine HCl 30 mg, and codeine phosphate 10 mg. Nonmedicinal ingredients: red colourant, flavour, glycerin, methylparaben, sodium benzoate, and sucrose. This medication does not contain alcohol.

How should I use this medication?

The recommended dose for adults and adolescents 12 years and over is 10 mL (2 teaspoons) or 1 tablet, every 4 to 6 hours as needed.

The recommended dose for children 6 to 12 years old is 5 mL (one teaspoon) or one half tablet 3 to 4 times a day as needed.

The recommended dose for children 2 to 6 years is 2.5 mL (one-half teaspoon) or one quarter tablet 3 to 4 times a day as needed.

In all cases, no more than 4 doses should be taken in a 24-hour period.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under "What form(s) does this medication come in?"

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to codeine, triprolidine, pseudoephedrine, or any of the ingredients of the medication
  • are allergic to codeine-like narcotics, other similar antihistamines, or decongestants
  • are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the past 2 weeks
  • are 12 years of age or younger
  • have a head injury or increased pressure inside the brain
  • have an ongoing or persistent cough
  • have decreased kidney function
  • have pheochromocytoma (a type of adrenal gland tumour)
  • have severe coronary artery disease
  • have severe high blood pressure
  • have severely reduced liver function
  • have ulcerative colitis (inflammation of the digestive tract)

This medication should not be given to newborn or premature infants.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • difficulty sleeping
  • dizziness
  • drowsiness
  • dry mouth
  • insomnia
  • jitteriness
  • lightheadedness
  • nausea
  • skin rash
  • vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • difficulty urinating
  • increased heart rate
  • itchy skin
  • unusual excitement or restlessness (especially in children)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • hallucinations (seeing or hearing things that are not there)
  • seizures
  • signs of intolerance to pseudoephedrine (e.g., drowsiness, dizziness, weakness, difficulty breathing, rapid heart rate)
  • symptoms of overdose of codeine, such as:
    • abnormally slow or weak breathing
    • cold, clammy skin
    • confusion
    • extreme drowsiness
    • severe dizziness
    • slow heartbeat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

July 28, 2016

Health Canada has issued new information concerning the use of prescription codeine. To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

A previous advisory on codeine was issued on June 6, 2013. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abdominal conditions: Codeine may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breathing: Codeine can suppress breathing. If you are at risk for breathing difficulties, such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Constipation: Codeine can be very constipating. Eating a high-fibre diet and following good bowel habits will help to minimize this effect. If you develop constipation easily, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains codeine. Physical dependence, psychological dependence, and abuse have occurred with the use of codeine. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief.

If you suddenly stop taking this medication, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Diabetes: The pseudoephedrine in this medication may cause blood sugar to become less controlled for people with diabetes. It may become necessary to test your blood glucose levels more often when taking codeine - triprolidine - pseudoephedrine - guaifenesin.

If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Codeine may cause drowsiness. Do not drive, operate machinery, or perform any potentially hazardous tasks until you have made sure that this medication does not make you drowsy.

Glaucoma: Codeine - triprolidine - pseudoephedrine may make glaucoma worse. If you have narrow-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Head injury: If you have a head injury or increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: This medication may make symptoms of certain heart conditions worse. If you have an irregular heart rhythm, ischemic heart disease, high blood pressure or other heart condition, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver disease: If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other medical conditions: If you are about to undergo surgery of the biliary tract, approach taking codeine with caution, as it may worsen your condition. Codeine will worsen the effects of acute alcohol intoxication and delirium tremens.

As well, if you have low thyroid (hypothyroidism), Addison's disease, benign prostatic hypertrophy (enlarged prostate), gallbladder disease, urethral stricture, decreased function of the adrenal glands, or porphyria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. Some of the codeine dose is converted into morphine by the body, once it has been taken. For some people, this change happens much faster than for others. If this happens to a nursing mother, the baby is a risk of receiving a morphine overdose through the breast milk. If you are a breast-feeding mother and are taking codeine - triprolidine - pseudoephedrine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication may cause either mild stimulation or mild sedation. Overdosage in infants and children may produce hallucinations and convulsions. Codeine - triprolidine - pseudoephedrine should not be given to children under 2 years old.

Seniors: This medication is more likely to cause side effects for those 60 years of age and older. Lower doses may be necessary.

What other drugs could interact with this medication?

There may be an interaction between codeine - triprolidine - pseudoephedrine and any of the following:

  • alcohol
  • amphetamines
  • anesthetics
  • anticholinergic medications (e.g., atropine, scopolamine)
  • antihistamines that cause drowsiness (e.g., chlorpheniramine, diphenhydramine)
  • barbiturates (e.g., phenobarbital, butalbital)
  • benzodiazepines (e.g., diazepam, lorazepam, oxazepam)
  • buprenorphine
  • bupropion
  • butorphanol
  • chloral hydrate
  • cimetidine
  • delaviridine
  • monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, tranylcypromine)
  • methocarbamol
  • nalbuphine
  • naltrexone
  • other narcotic pain relievers (e.g., fentanyl, hydrocodone, morphine)
  • pentazocine
  • phenothiazines (e.g., chlorpromazine, prochlorperazine)
  • protease inhibitors (e.g., daraunavir, indinavir, lopinavir, ritonavir, saquinavir)
  • quinidine
  • rifampin
  • selegiline
  • SSRIs (e.g., duloxetine, fluvoxamine, paroxetine, sertraline)
  • terbinafine
  • thiopental
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline)
  • venlafaxine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.