Language selection

Search

Details for: REACTINE COMPLETE

Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02246162REACTINE COMPLETECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5 MG; 120 MGTABLET (EXTENDED-RELEASE)ORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Over-the-Counter Products Containing Pseudoephedrine - Assessing the Potential Risk of Inflammation and Injury of the Large Intestine due to Insufficient Blood Supply (ischemic colitis)

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

REACTINE COMPLETE is indicated for the fast, long lasting relief of itchy watery eyes, sneezing, runny nose and nasal congestion caused by seasonal allergies (hay fever, trees, grass, pollen and ragweed) and perennial allergies (dust mites, animal dander and molds).

What it does

Your allergy symptoms are simply your body’s over reaction in trying to protect you from allergens such as dust, ragweed, grass and tree pollen, animal dander or mold. When allergens are detected, your body rushes a substance called histamine to histamine receptor sites in your skin and tissues. The resulting reaction causes itchy, watery eyes, sneezing and runny nose. REACTINE (cetirizine hydrochloride) helps relieve your allergy symptoms by blocking these receptor sites before histamine binds there. The pseudoephedrine component of REACTINE COMPLETE is recognized as an effective agent for the relief of nasal congestion caused by your allergies.

What other things can I do for my allergies?
Keep pollens out. Keep windows closed. Use an air conditioner.
Stay informed about pollen seasons and levels in your region.
Plan outdoor activities. Stay inside on warm and windy days. Most plants pollinate in the morning. Stay indoors until later.
Stay away from big pollen producers like birch, ash, maple, oak and walnut trees.
Hire someone to cut your grass. Remove pets if possible. Keep them out of bedrooms. Keep a dust-free home. Remove carpets, keep furnace ducts clean and vacuum often.
Control dust mites. Encase your mattress in a proper dust mite barrier and wash bedding often in very hot water.
Stay away from those foods, medications, insects, or even dyes and plants, that may cause itchy, irritating rashes called hives (urticaria).

What causes my nasal congestion?
Typically, prolonged allergy attacks will be the cause of nasal congestion, however, other causes include: exposure to tobacco smoke; dust or airborne pollutants; swimming in polluted water or overuse of non-prescription nasal sprays.

What other things can I do for nasal congestion?
Stay away from airborne irritants: cigarette smoke and other air pollutants.
Avoid alcohol intake as it can cause sinus membranes to swell.
Avoid swimming in pools treated with chlorine as it can irritate the lining of the nose and sinuses.
Beware of situations which can result in sinus pressure, such as flying, due to low cabin pressure.
Adopt sleeping positions that are either slightly propped up or on one side or the other.

When it should not be used
  • Do not use REACTINE COMPLETE if you are allergic to cetirizine hydrochloride, to its parent compound, hydroxyzine, or to piperazine derivatives. Additionally, do not use this product if you have a known hypersensitivity or history of unusual reactions to pseudoephedrine hydrochloride, to other stimulants, or to any of the ingredients in the formulation or components of the container. For a complete listing of the nonmedicinal ingredients present in REACTINE COMPLETE, see What the nonmedicinal ingredients are.
  • As a result of the pseudoephedrine hydrochloride component, you should not use this product if you have any of the following conditions: glaucoma, problems urinating, if you are taking some antidepressant medications, or within 14 days of stopping such treatment. REACTINE COMPLETE should also not be used if you have high blood pressure, heart disease, problems with blood circulation, or an overactive thyroid gland.
  • REACTINE COMPLETE should not be used in children under 12 years of age.

What the medicinal ingredient is

Each tablet contains 5 mg cetirizine hydrochloride in an immediate release layer and 120 mg pseudoephedrine hydrochloride in an extended release layer.

What the non-medicinal ingredients are

Croscarmellose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.

What dosage form it comes in

REACTINE COMPLETE Tablets are white round, biconvex tablets containing 5 mg cetirizine hydrochloride in an immediate release layer and 120 mg pseudoephedrine hydrochloride in an extended release layer. Tablets are debossed with “REACTINE +” on one side. PVC film and aluminum foil blister packages of 10 and 30.

Warnings and precautions

Before you use REACTINE COMPLETE, talk to a doctor or pharmacist if you have or have had: narrowangle glaucoma, urinary retention due to prostate gland enlargement, severe hypertension (high blood pressure), severe coronary artery disease (heart disease), thyroid disease, diabetes, receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping such treatment, or are taking any prescription drugs, nonprescription drugs, or natural health products. Talk to a doctor before using this product if you are pregnant, breastfeeding, or if you have liver or kidney disease. Your doctor should determine if a different dose is needed. If signs and symptoms such as formation of small pimples occur, with or without fever or redness, then treatment with REACTINE COMPLETE should be discontinued and a doctor should be consulted. Some people can experience drowsiness due to allergies or antihistamine use. If drowsiness does occur, do not drive or operate machinery. If symptoms persist or worsen, or if new symptoms occur, stop use and consult a doctor. KEEP OUT OF REACH OF CHILDREN.

Interactions with this medication

Do not use REACTINE COMPLETE with sedating substances such as alcohol and some other medications, including: anti-anxiety medications sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics. Drugs that may interact with pseudoephedrine include: Monoamine oxidase (MAO) inhibitors, methyldopa, mecamylamine, guanethidine, reserpine, veratrum alkaloids, beta-adrenergic blocking agents, digitalis, furazolidone, other sympathomimetic amines, antacids and kaolin.

Proper use of this medication

Usual Dose

Do not exceed recommended dosage unless directed by a doctor. The tablets should be swallowed with liquid and should not be divided, chewed or crushed. May be taken with or without food. Prolonged use only as directed by a doctor.

Adults and children 12 years of age and over: The recommended dose of REACTINE COMPLETE is one tablet every 12 hours.
Adults 65 years of age and over and in patients with moderate liver and/or kidney disease: A dose of one tablet once daily is recommended.

Overdose

Acute overdosage with REACTINE COMPLETE may produce abnormally rapid beating of the heart, other abnormal heartbeat, high blood pressure, signs of CNS depression (for example: sleepiness, breathing disturbances, unconsciousness, bluish colouration of the skin or mucous membranes, and cardiovascular collapse) or stimulation (insomnia, hallucinations, tremor, seizures), which could be fatal.

In case of suspected overdose or if any of these symptoms occur, stop taking the drug and immediately contact your doctor or the Poison Control centre at once.

Treatment in a hospital setting is preferred. Notify of any other medications you may have been taking. If emergency help is not available, vomiting should be induced at once by Syrup of Ipecac. VOMITING SHOULD NEVER BE INDUCED IN UNCONSCIOUS INDIVIDUALS OR IN CHILDREN UNDER 1 YEAR WITHOUT MEDICAL HELP.

Missed Dose

If you miss taking your dose on time, do not worry; take your dose when you remember. Do not take more than one dose in 24 hours.

Side effects and what to do about them

The most common side effects associated with cetirizine hydrochloride use are headache, sleepiness and dry mouth. If these side effects do not go away, call your doctor or pharmacist.

The following side effects have been reported very rarely: aggression, agitation, hallucination, memory impairment/ amnesia, insomnia, dizziness, loss of taste, erectile dysfunction, eye pain or swelling and blurred vision.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Restlessness with increased body movement    
Difficulty urinating    
New rash or itching after stopping drug    
Liver dysfunction (inflammation of the liver, appearance of jaundice, i.e. yellowing of the skin)    

This is not a complete list of side effects. For any unexpected effects while taking Cetirizine and Pseudoephedrine, contact your doctor or pharmacist

How to store

Store between 15 °C and 30 °C.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/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.

More information

Questions about REACTINE Complete? 1-87- REACTINE www.reactine.ca

Product Monograph available to doctors and pharmacists upon request.

McNeil Consumer Healthcare, division of Johnson & Johnson Inc.
©Johnson & Johnson Inc. 2019

Last Revised: May 17, 2019

Date modified: