Details for: SUDAFED SINUS ADVANCE
Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02242217 | SUDAFED SINUS ADVANCE | PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 30 MG; 200 MG | TABLET | ORAL |
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
Relief of the symptoms of colds including nasal congestion, sinus pain, headache, fever, body aches and pains.
What it does
Ibuprofen reduces pain and fever. Pseudoephedrine hydrochloride is a nasal decongestant.
When it should not be used
Do not use SUDAFED SINUS ADVANCE if you have or are:
- taking daily low dose ASA (81-325 mg) without talking to a doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.
- taking other salicylates or other anti-inflammatory agents including ibuprofen.
- taking a monoamine oxidase inhibitor (MAOI) (e.g. drugs for depression or Parkinson’s), or you have stopped taking an MAOI less than 14 days.
- shown sensitivity to its ingredients (ibuprofen, pseudoephedrine) or the nonmedicinal ingredients (see complete list of nonmedicinal ingredients), or if allergic to products containing ASA, other salicylates or other anti-inflammatory agents.
- underlying condition, that requires continued use for more than 5 days. Overuse is hazardous.
- if you are in your third trimester of pregnancy
- a child less than 12 years old.
- active peptic ulcer disease or gastrointestinal bleeding.
- nasal polyps (swollen growths inside the nose)
- experienced allergic reactions such as anaphylaxis (sudden severe life threatening allergic reaction) urticaria/hives, rhinitis (stuffed or runny nose) that may be due to allergies, skin rash or other allergic symptoms
- dehydrated (significant fluid loss) due to vomiting, diarrhea, or lack of fluid intake
- asthma
- severe high blood pressure or have heart disease
- about to or have had heart surgery
- serious liver disease
- severe kidney disease
- thyroid disease
- Raynaud’s disease (a disorder of the circulatory system)
- Systemic Lupus Erythematosus
What the medicinal ingredient is
Ibuprofen and pseudoephedrine hydrochloride
What the non-medicinal ingredients are
Calcium stearate, candelilla wax, croscarmellose sodium, hydroxypropyl methylcellulose, methylparaben, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium lauryl sulfate, stearic acid, titanium dioxide
What dosage form it comes in
SUDAFED SINUS ADVANCE® is supplied as white caplets, for oral administration containing 200 mg ibuprofen and 30 mg pseudoephedrinehydrochloride.
Warnings and precautions
Serious Warnings and Precautions
SUDAFED SINUS ADVANCE®should be used only under the supervision of a doctor in patients with the following conditions:
- history of active peptic ulcer disease or gastrointestinal bleeding. The chance of stomach bleeding is higher if you are: age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other drugs containing an NSAID like acetylsalicyclic acid (ASA), ibuprofen, naproxen, or prescription antiinflammatory drugs, have 3 or more alcoholic drinks every day while using this product.
- risk of kidney problems, including the elderly or those using diuretics
- if you trying to conceive, in your first or second trimester of pregnancy or nursing
- high blood pressure,
- heart disease,
- diabetes,
- narrow angle glaucoma,
- thyroid disease,
- difficulty in urination due to enlargement of the prostate gland
BEFORE you use SUDAFED SINUS ADVANCE®talk to your doctor or pharmacist if you have
- High blood pressure, heart disease
- Aseptic meningitis, fever, or rash
- Diabetes
- Mild to moderate kidney or liver disease.
- Glaucoma or blurred vision.
- Blood clotting disorder such as hemophilia
- Breathing problems or chronic lung disease (such as chronic bronchitis)
- Other serious diseases, are under doctor’s care for any serious condition, or are taking any other drug including over the counter drugs.
Interactions with this medication
Drugs that may interact with SUDAFED SINUS ADVANCE®
include: Antidepressants, monoamine oxidase (MAO) inhibitors,
anticoagulants (blood thinning medications), Acetylsalicylic Acid
(ASA), other Nonsteroidal anti-inflammatory drugs (NSAIDs),
including naproxen and ibuprofen, acetaminophen, antidiabetic
agents and insulin, furosemide and other diuretics (water pills),
pindolol, digoxin, phenytoin, and lithium salts, allergy
medications, anti-hypertensives (blood pressure medications),
antibiotics, benzodiazepines, cold medications, corticosteroids,
cyclosporine, diabetes medication, (including insulin and oral
antidiabetic drugs), methotrexate.
Tell your doctor or pharmacist what prescription or nonprescription drugs you are taking or plan to
take.
Do not smoke or drink alcohol while using this product.
Proper use of this medication
Usual Dose
- Adults 65 years and under and children 12years and older: Take 1 or 2 caplets every four to six hours as needed. Do not exceed six caplets in 24 hours, unless directed by a physician.
- Do not give to children under 12 years of age.
- Do not use longer than 3 days for a fever or 5 days for pain or cold symptoms.
- Keep out of reach of children. Each package contains sufficient medicine to seriously harm a child.
Overdose
In case of accidental overdose, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.
Signs of overdose include nausea, heartburn or stomach pain, dizziness, headache or nervousness, rapid eye movement or lack of response to moderate pain, respiratory distress (breathing may be rapid and deep or shallow), flushing or bluish colouration of skin or mucous membranes, rapid, weak heartbeats or palpitations. 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. If emergency help is not available, vomiting should be induced at once (within 30 minutes) by syrup of ipecac. VOMITING SHOULD NEVER BE INDUCED IN UNCONCIOUS INDIVIDUALS OR IN CHILDREN UNDER 1 YEAR WITHOUT MEDICAL HELP.
Missed Dose
Continue to take 1 or 2 caplets every 4 to 6 hours as needed after a missed dose. Do not take twice the recommended dose following a missed dose.
Side effects and what to do about them
If sudden abdominal pain or chronic abdominal pain with loss of
appetite and /or new onset of itching, heartburn, nausea or
vomiting, bloating, diarrhea or constipation, ringing or buzzing in
the ears, dizziness or any change in vision, nervousness or
sleeplessness, fluid retention, itching, skin rashes or any other
side effect or unexplained symptoms develop while taking
SUDAFED SINUS ADVANCE®, discontinue use immediately
and contact a physician.
The risk of having side effects may be decreased by using the
smallest dose for the shortest duration of time.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| abdominal pain, heartburn, nausea or vomiting, bloating, ringing or buzzing in the ears, dizziness or any change in vision, fluid retention, itching, skin rashes, redness, blisters, breathing problems | ✔ | ✔ | |
| Uncommon | |||
| diarrhea bleeding, severe itching, swelling of lymph nodes, blood in vomit, bloody or black stools jaundice | ✔ | ||
| constipation, cramps, redness, headache, nervousness, insomnia, vivid dreams, decreased appetite | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking SUDAFED SINUS ADVANCE®, contact your doctor or pharmacist.
How to store
Recommended storage condition is between 15 and 30 °C. Protect from light. Keep dry.
Reporting side effects
Reporting Suspected Side Effects
- You can report any suspected side effects associated with the use of health products to Health Canada by: Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals is available from McNeil Consumer
Healthcare, Markham, Ontario, L3R 5L2,
This leaflet was prepared by McNeil Consumer Healthcare
division of Johnson & Johnson Inc. ©J&J Inc. 2020
Last revised: April 8, 2020