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 |
|---|---|---|---|---|---|
| 02246162 | REACTINE COMPLETE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5 MG; 120 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Summary Reports
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.
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.
| 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