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Coactifed (Glaxosmithkline, 2 mg / 30 mg / 10 mg): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) NARCOTICS (CDSA I) Current status: Cancelled Post Market
Strength:
2 mg / 30 mg / 10 mg
Active ingredients:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Coactifed (Glaxosmithkline, 2 mg / 30 mg / 10 mg)

Serious Warnings and Precautions

Taking COACTIFED® with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

What is COACTIFED® used for?

COACTIFED® is used for the temporary relief of cough associated with allergies or the common cold. For adults 18 years or older.

How does COACTIFED® work?

Triprolidine is an antihistamine. Pseudoephedrine is a decongestant. Codeine acts on the brain to suppress cough.

What are the ingredients in COACTIFED®?

Medicinal ingredients: Triprolidine hydrochloride, pseudoephedrine hydrochloride and codeine phosphate.

Non-medicinal ingredients: Flavour, glycerine, methylparaben, red colourant, sodium benzoate and sucrose. Alcohol-free.

COACTIFED® comes in the following dosage forms:

2 mg triprolidine, 30 mg pseudoephedrine, 10 mg codeine in 5 mL of syrup.

Do not use COACTIFED® if you:

  • are under 18 years of age

  • are pregnant, or in labor or delivery

  • are breastfeeding. The use of codeine-containing products while breast-feeding may harm your baby.

    If you breastfeed and take COACTIFED®, seek immediate medical care for your baby if they are overly drowsy, sedated, have difficulty breast-feeding, have breathing difficulties, and are floppy (have decreased muscle tone). This is very serious for the baby and can lead to death. Tell the baby’s doctor that you are breastfeeding and took COACTIFED®.

  • have been told by your doctor that you break down codeine rapidly. This can lead to codeine overdose even at the usual adult dose.
  • have a chronic cough that occurs with asthma, smoking or emphysema, or when there is an unusually large amount of mucus or phlegm with the cough
  • have a head injury or increased pressure in your head
  • are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
  • have severe high blood pressure or heart condition
  • have severe liver or kidney problems
  • have pheochromocytoma (adrenal gland tumour)
  • have ulcerative colitits
  • are at risk for having seizures
  • are allergic to this drug, other opioids or other antihistamines, to parabens (product contains methylparaben) or to any ingredient in the formulation (see “What are the ingredients in COACTIFED®?”)
  • have severe asthma, trouble breathing, bronchitis, emphysema or other breathing problems
  • have bowel blockage or narrowing of the stomach or intestines
  • suffer from alcoholism
  • are taking medicines for cough and cold, Attention Deficit and Hyperactivity Disorder (ADHD) or to decrease appetite

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take COACTIFED®. Talk about any health conditions or problems you may have, including if you:

  • have a history of illicit or prescription drug or alcohol abuse
  • have high or low blood pressure, heart disease or a heart condition, liver or kidney problems, diabetes, glaucoma, thyroid disease, gallbladder disease including gallstones, enlarged prostate or difficulty in urinating, ulcers, bowel obstruction or abdominal pain or infections (such as an inflamed appendix or pancreas), or epilepsy.
  • have chronic or severe constipation
  • are older than 65 years old, or suffer from a long-term illness.
  • have asthma, a persistent or chronic cough or any other respiratory complications (i.e., difficulty breathing).
  • are pregnant or planning to become pregnant.
  • are breastfeeding
  • have or had depression
  • are taking tranquilizers, sedatives, sedating antihistamines or other depressants.
  • are taking any other drug including over the counter drugs.
  • have diabetes, as COACTIFIED® contains sucrose.

Other warnings you should know about:

Accidentally taking COACTIFED® can result in a fatal overdose. This is especially true if a child accidently takes it. Keep COACTIFED® out of sight and reach of children.

As with all opioids, taking COACTIFED® may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor.

If you took COACTIFED® while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:

  • has changes in their breathing (such as weak, difficult or fast breathing)
  • is unusually difficult to comfort
  • has tremors (shakiness)
  • has increased stools, sneezing, yawning, vomiting, or fever

Seek immediate medical help for your baby.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to COACTIFED®. COACTIFED® can cause:

  • drowsiness
  • dizziness or
  • lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

COACTIFED® is not recommended for anyone who has or is at risk for breathing problems such as:

  • lung infections, or respiratory conditions
  • neuromuscular disorders
  • severe heart problems
  • recent multiple traumas or extensive surgical procedures

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with COACTIFED®:

  • other cough suppressants (antitussives) or decongestant medications
  • antihistamines (drugs used to treat allergies)
  • antidepressants (for depression and mood disorders). Do not take COACTIFED® with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
  • drugs used to treat serious mental or emotional disorders (such as schizophrenia)
  • medications for high blood pressure or heart conditions, (like beta blockers)

  • alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking COACTIFED®. It can lead to:

    • drowsiness
    • unusually slow or weak breathing
    • serious side effects or
    • a fatal overdose
  • opioid analgesics (drugs used to treat pain)
  • general anesthetics (drugs used during surgery)
  • benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
  • Domperidone and metoclopramide often used for nausea and vomiting and to help food move through digestion.
  • anti-emetics (drugs used to prevent vomiting)
  • drugs used to treat muscle spasms and back pain

How to take COACTIFED®:

Always take COACTIFED® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor should prescribe COACTIFED® at the lowest effective dose for the shortest period of time. It should only be used as needed. Do not take a dose unless you currently need it for cough. Do not use for more than 3 days unless you are told to by your healthcare professional.

Usual Adult dose:

Do not exceed 4 doses in 24 hours.

Adults: 10 mL syrup three or four times a day

Overdose:

If you think you have taken too much COACTIFED®, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include:

  • unusually slow or weak breathing
  • dizziness
  • confusion
  • extreme drowsiness
  • feeling sick
  • vomiting
  • constipation, decreased or lack of appetite.

Missed Dose:

As there is no scheduled dosing, take COACTIFED® as needed for cough. Do not exceed 4 doses in 24 hours.

What are possible side effects from using COACTIFED®?

These are not all the possible side effects you may feel when taking COACTIFED®. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • drowsiness
  • headache
  • dizziness
  • problems with vision
  • weakness, uncoordinated muscle movement
  • vertigo
  • lightheadedness, fainting
  • Difficulty sleeping, nightmares, disturbance in attention
  • nervousness, agitation, restlessness, mild stimulation
  • shortness of breath
  • nausea, vomiting, or a poor appetite
  • bloating
  • dry mouth, nose and/or throat
  • skin rash, itching or hives
  • sweating
  • constipation

Consult your doctor if you feel sedated or drowsy, confused, have shallow breathing or have severe constipation.

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases

COMMON

Drowsiness

✓

Depression: feeling sad, unexplained weight change, sleep disturbances, lack of interest in usual activities,

confused

✓

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
Low Blood Pressure: dizziness, fainting, lightheadedness✓
Difficult or painful urination, urine retention✓
Visions Changes: blurred vision, glaucoma or other eye disorder✓
Thickening of secretions (phlegm) from the lungs✓
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting✓

RARE

Encephalopathy (brain injury) : altered mental state, confusion, inability to concentrate, lethargy

✓

Cerebral vasoconstriction syndrome: sudden, severe headache,

Nausea, vomiting, visual disturbances

✓

Codeine Overdose:

hallucinations, inability to walk normally, slow or weak breathing, extreme sleepiness, confusion, sedation, or dizziness, feeling sick, vomiting, constipation, decreased or lack of appetite, floppy muscles/low muscle tone

cold and clammy skin.

✓

Respiratory Depression:

Slow, shallow or weak breathing.

✓
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing✓

Bowel Blockage (impaction):

abdominal pain, severe constipation, nausea

✓

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases

Ischemic colitis:

sudden abdominal pain, rectal bleeding or bloody stools

✓
Fast, Slow or Irregular Heartbeat: heart palpitations.✓
Low Blood Pressure: dizziness, fainting, light-headedness.✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);

  • By completing a Consumer Side Effect Reporting Form and sending it by:

    • Fax to 1-866-678-6789 (toll-free), or

    • Mail to: Canada Vigilance Program

      Health Canada, Postal Locator 1908C Ottawa, ON

      K1A 0K9

      Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep unused or expired COACTIFED® in a secure place to prevent theft, misuse or accidental exposure to children and pets.

Keep COACTIFED® out of sight and reach of children and pets.

Store between 15°C and 30°C. Protect from light.

Disposal:

COACTIFED® should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about COACTIFED®:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website; the manufacturer’s website http://www.gsk.ca, or by contacting the sponsor;

GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

1-800-387-7374

Last revised: 14-MAR-2017

© 2017 GlaxoSmithKline Inc. All Rights Reserved

COACTIFED is a registered trademark, used under license by GSK Inc.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 00068594

Revision date stated in the text: March 2017

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Coactifed (Glaxosmithkline, 2 mg / 30 mg / 10 mg)

Rx or OTC
Prescription (Rx)?
DIN 00068594
Schedule(s) NARCOTICS (CDSA I)
Active ingredient(s) Triprolidine hydrochloride 2 MG, Pseudoephedrine hydrochloride 30 MG, Codeine phosphate 10 MG
Dosage form(s) Syrup
Route(s) of administration Oral
Drug class (WHO ATC)
  1. R Respiratory system drugs
    1. R05 Cough and cold preparations
      1. R05D Cough suppressants, excl. combinations with expectorants
        1. R05DA Opium alkaloids and derivatives, cough suppressants
          1. R05DA20 Combinations
Company GLAXOSMITHKLINE INC
Current status Cancelled Post Market
Current status date May 28, 2018

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.