Advil cold and sinus instructions

Contents

Advil Cold & Sinus

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

This product is a combination of 2 medications: ibuprofen and pseudoephedrine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation by reducing a substance in the body that leads to inflammation and pain. Pseudoephedrine is a decongestant that relieves the symptoms of nasal and sinus congestion by shrinking swollen nasal passages and sinuses.

This medication is used to relieve nasal congestion, sinus congestion, sinus pain, fever, headache, sore throat, and body aches and pains that are associated with the common cold, sinusitis, or the flu.

Your doctor or pharmacist may have suggested this medication for conditions other than the ones listed in this drug information article. 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 or pharmacist.

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 or pharmacist has not recommended it.

What form(s) does this medication come in?

Liqui-Gels
Each light gold liquid-filled gelatin capsule contains 200 mg of ibuprofen and 30 mg of pseudoephedrine. Nonmedicinal ingredients: D&C Yellow No. 10, FD&C Red No. 40, fractionated coconut oil, gelatin, iron oxide, polyethylene glycol, polyvinyl acetate phthalate, potassium hydroxide, propylene glycol, purified water, sorbitan, and sorbitol.

Caplets
Each beige, sugar coated caplet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine. Nonmedicinal ingredients: acetylated monoglyceride, ammonium hydroxide, carnauba wax, cellulose, cornstarch, croscarmellose sodium, iron oxides, parabens, pharmaceutical glaze, pharmaceutical shellac, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, and titanium dioxide.

Daytime
Each caplet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine. Nonmedicinal ingredients: acetylated monoglycerides, carnauba wax, cellulose, cornstarch, croscarmellose sodium, ethoxyethanol, iron oxides, lecithin, parabens, pharmaceutical glaze, pharmaceutical shellac, povidone, pregelatinized starch, silicon dioxide, simethicone, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, and titanium dioxide.

How should I use this medication?

The usual recommended dose for adults and children older than 12 years is 1 or 2 caplets or liqui-gels every 4 to 6 hours as needed. Do not take more than 6 caplets or liqui-gels in 24 hours unless recommended by your doctor. Do not take for more than 3 days for a fever or for more than 5 days for cold symptoms.

For the children’s suspension, the dose depends on the child’s age and weight and is given every 6 hours as needed. Do not give more than 4 doses a day unless recommended by your doctor. Use an oral syringe or medication cup to measure each dose of the suspension, as it gives a more accurate measurement than household teaspoons. Shake the suspension well before pouring a dose.

Many things can affect the dose of 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 one listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as recommended by your doctor or pharmacist. If you are taking this medication regularly and you miss a dose, take it as soon as possible. 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 and keep it out of the reach of children.

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 take this medication if you:

  • are allergic or sensitive to ibuprofen, pseudoephedrine, or any ingredients of the medication
  • are allergic to other NSAIDs (e.g., naproxen, ketoprofen, diclofenac) or ASA,
  • are about to have or have just had heart surgery
  • are dehydrated due to vomiting, diarrhea, or not drinking enough fluids
  • are taking another NSAID (e.g., naproxen, diclofenac, ketoprofen)
  • are pregnant or breast-feeding
  • have a stomach ulcer, intestinal ulcer, ulcerative colitis, or Crohn’s disease
  • have angioedema syndrome
  • have experienced wheezing or difficulty breathing from ASA or other NSAIDs (e.g., naproxen, diclofenac, ketoprofen)
  • have kidney disease, reduced or worsening kidney function
  • have nasal polyps
  • have Raynaud’s Syndrome
  • have serious liver disease or reduced liver function
  • have severe heart disease
  • have severe high blood pressure
  • have systemic lupus erythematosus
  • have taken a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) within the last 14 days
  • have thyroid disease

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.

  • bloating or gas
  • constipation
  • diarrhea
  • difficulty sleeping
  • heartburn
  • nausea
  • nervousness
  • stomach cramps
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

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

  • blurred vision or other eye symptoms
  • dizziness
  • fast, pounding heartbeat (palpitations)
  • fluid retention
  • ringing in the ears
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)

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

  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • symptoms of a severe allergic reaction (difficulty breathing, hives, swelling of the mouth or throat)

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.

Allergy: Some people who are allergic to acetylsalicylic acid (ASA) or other anti-inflammatory medications also experience allergic reactions to ibuprofen. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially anti-inflammatory medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Bleeding problems: If you have bleeding problems (e.g., hemophilia) or are taking anticoagulants (e.g., warfarin), you should not take this medication, unless recommended by your doctor.

Dependence and withdrawal: Physical dependence can occur with the use of pseudoephedrine for too long a period of time or at doses that are greater than the recommended amount. If this medication is stopped suddenly after using it for longer than recommended or at high doses, you may experience withdrawal symptoms such as anxiety, agitation, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Diabetes: Ibuprofen – pseudoephedrine may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing 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 and dizziness: This medication can cause drowsiness and dizziness that may affect your ability to drive or operate machinery safely. If this medication affects you this way, do not perform these tasks.

Fluid retention: This medication can cause fluid retention. If you have heart failure or high blood pressure, fluid retention may worsen your condition. If you notice worsening of the symptoms of heart failure or your blood pressure increases while taking this medication, contact your doctor.

General: If your symptoms do not improve contact your doctor. Do not use this medication for longer than 3 days for a fever or 5 days for pain or cold symptoms without consulting your doctor or pharmacist.

Glaucoma: This medication may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have 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. Report any changes in vision to your doctor as soon as possible while you are taking this medication.

Heart problems: The cardiovascular system (heart and blood vessels) may be affected by the use of this medication. Ibuprofen can cause fluid to build up in the body. This alone can cause increased blood pressure and symptoms of congestive heart failure to become worse.

Pseudoephedrine can cause blood vessels to narrow, increasing blood pressure. It may also cause increased heart rate or irregular heart beat. If you have a history of heart attack, angina, stroke or other conditions that can be worsened by changes to the heart and blood vessels, 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 problems: This medication may cause kidney problems. If you have reduced kidney function, heart failure, are taking diuretics (e.g., hydrochlorothiazide, furosemide), or are a senior, 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.

Medical conditions: If you have heart disease, high blood pressure, thyroid disease, narrow angle glaucoma, diabetes, or difficulty in urination due to enlargement of the prostate gland, you should not take this medication unless directed by a doctor.

Stomach ulcers and bleeding: Ibuprofen may cause ulcers or bleeding in the stomach or intestines. If you experience black, tarry stools, vomit that looks like coffee grounds, or stomach pain while taking this medication, contact your doctor immediately. If you have a history of stomach problems, discuss with your doctor or pharmacist how this medication may affect your medical condition and whether any special monitoring is needed.

Thyroid problems: If you have a thyroid condition, this medication may cause symptoms of overactive thyroid. If you are taking medications for an overactive thyroid or experience symptoms such as feeling hot all the time, weight loss without a change in your diet or amount of exercise you get, or feeling emotional, contact your doctor.

Urinary tract problems: This medication may cause bladder pain, painful or difficult urination, or increased frequency of urination. If you have an enlarged prostate gland, the difficulty urinating may be more pronounced. If these symptoms occur without an explanation (e.g., infection), stop taking this medication and contact your doctor.

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

Breast-feeding: This medication should not be used while breast-feeding.

Children: The caplets and liquid-gels should not be given to children less than 12 years old. The liquid form of the medication should not be given to children less than 6 years old.

Seniors: Seniors may be more likely to experience side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between ibuprofen – pseudoephedrine and any of the following:

  • acetazolamide
  • acetylsalicylic acid (ASA)
  • alcohol
  • aliskiren
  • alpha agonists (e.g., clonidine, methyldopa)
  • aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • angiotensin-coverting enzyme inhibitors (ACEIs; captopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • anticoagulants (e.g., dalteparin, enoxaparin, warfarin, apixaban, dabigatran, rivaroxaban)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
  • apixaban
  • atomoxetine
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • bimatoprost
  • bismuth subsalicylate
  • bisphosphonates (e.g., alendronate, etidronate)
  • brinzolamide
  • bromocriptine
  • cabergoline
  • caffeine
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • celecoxib
  • cilostazol
  • cholestyramine
  • clopidogrel
  • colestipol
  • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • dasatinib
  • decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
  • decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
  • deferasirox
  • desmopressin
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • digoxin
  • dipiverin
  • dipyridamole
  • diuretics (e.g., hydrochlorothiazide, furosemide, triamterene)
  • dobutamine
  • dopamine
  • dronabinol
  • drospirenone
  • eplerenone
  • epinephrine
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • fast-acting bronchodilators (e.g., salbutamol, terbutaline)
  • glucosamine
  • herbs that may increase the risk of bleeding (e.g., cat’s claw, dong quai, feverfew, garlic, ginger)
  • imatinib
  • latanoprost
  • linezolid
  • lithium
  • long-acting bronchodilators (e.g., formoterol, salmeterol)
  • MAO inhibitors (i.e., moclobemide, phenelzine, selegilene)
  • mesalamine
  • methotrexate
  • methylphenidate
  • nabilone
  • norepinephrine
  • other NSAIDs (e.g., naproxen, diclofenac, ketorolac)
  • pemetrexed
  • probenecid
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
  • sulfasalazine
  • tacrolimus
  • tenofovir
  • thyroxine
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • ticagrelor
  • ticlopidine
  • tipranavir
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • vancomycin
  • vitamin E

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 that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, and street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Advil-Cold-Sinus

Advil cold sinus tablets

Active Ingredients (in each tablet or caplet):

Ibuprofen 200 mg

Pseudoephedrine HCl 30 mg

Active Ingredients (in each LiquiGel):

Solubilized Ibuprofen equal to 200 mg ibuprofen (present as the free acid and potassium salt)

Pseudoephedrine HCl 30 mg

Uses: Temporarily relieves these symptoms associated with the common cold, sinusitis or flu:

· headache · fever · nasal congestion · minor body aches and pains

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock

Stomach bleeding warning: Taking more than recommended may cause stomach bleeding

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen may cause stomach bleeding.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

  • heart disease · high blood pressure
  • thyroid disease · diabetes
  • trouble urinating due to an enlarged prostate gland
  • had problems or serious side effects from taking pain relievers or fever reducers
  • kidney disease
  • ulcers
  • bleeding problems
  • stomach problems that last or come back, such as heartburn, upset stomach or pain

Ask a doctor or pharmacist before use if you are

  • taking any other product that contains ibuprofen or any other pain reliever/fever reducer
  • taking any other product that contains pseudoephedrine or any other nasal decongestant
  • under a doctor’s care for any continuing medical condition
  • over 65 years of age
  • taking a prescription product for anticoagulation (blood thinning) or a diuretic
  • taking any other drug
  • taking aspirin for cardioprotection

When using this product

  • do not use more than directed
  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you get nervous, dizzy, or sleepless
  • nasal congestion lasts for more than 7 days
  • fever lasts for more than 3 days
  • symptoms continue or get worse
  • any new symptoms appear
  • stomach pain occurs with use of this product or if even mild pain persists

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

  • adults and children 12 years of age and over:
    • take 1 tablet, caplet or liqui-gel every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 tablet, caplet or liqui-gel, 2 tablets, caplets or liqui-gels may be used.
    • do not use more than 6 tablets, caplets or liqui-gels in any 24-hour period unless directed by a doctor
    • the smallest effective dose should be used
  • children under 12 years of age: consult a doctor

Other Information:

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.
  • each Liqui-gel contains: potassium 20 mg

Inactive Ingredients (tablets and caplets): carnauba or equivalent wax, croscarmellose sodium, iron oxides, methylparaben, microcrystalline cellulose, propylparaben, silicon dioxide, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, sucrose, titanium dioxide

How Supplied: Advil Cold and Sinus is an oval-shaped, tan-colored caplet, a tan-colored tablet or a liqui-gel. The caplet is supplied in blister packs of 20 and 40. The tablet is available in blister packs of 20. The liqui-gel is available in blister packs of 16 and 32.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Advil Cold & Sinus: Overview of Mild & Severe Side Effects

How does Advil Cold & Sinus work to treat a sinus infection?

Advil Cold & Sinus is one of the most popular over-the-counter treatments for colds and sinus infections. The active ingredients, chlorpheniramine, ibuprofen and pseudoephedrine are found not only in Advil Cold & Sinus (the name-brand medication) but also in its generic counterparts.

Advil Cold & Sinus works to reduce the inflammation of the sinus passages and the build-up of excess mucus. The medication decreases sinus congestion and difficulty breathing by reducing swelling of the nasal tissues that restrict your airways. Advil also acts as a general pain reliever to ease the discomfort of sinus pressure. You can find Advil Cold & Sinus at your local pharmacy.

When suffering from the pain of a sinus infection we often jump at the quickest and easiest over-the-counter medication. Before reaching for the box of Advil at the drugstore at the onset of sinus congestion, take care to read the facts below concerning side effects. Even if you are not at risk for the serious side effects, it is important to remain aware of the milder, more common things you might experience before using this medication.

What are the mild and more common side effects of Advil Cold & Sinus?

All medications have side-effects. Consumers taking Advil Cold & Sinus potentially have a wide range of side effects. For example, the most common symptoms experienced by sinus sufferers after taking the medication include:

  • Constipation
  • Diarrhea
  • Dizziness
  • Tinnitus (Ringing in the ears)
  • Slight drowsiness
  • Minor headache
  • Decreased appetite
  • Mild Nausea
  • Anxiety
  • Insomnia or difficulty sleeping
  • Upset stomach
  • Vomiting
  • General weakness

What are the severe and less common side effects of Advil Cold & Sinus?

Although it is unlikely that you will experience any of the uncommon side effects of Advil Cold & Sinus, take care to read over the list carefully. If you notice any of these symptoms, call 911 and seek immediate medical attention.

  • Severe allergic reactions
  • Severe chest pain
  • Irregular heartbeat
  • Numbness in extremities
  • Persistent drowsiness
  • Seizures
  • Severe vomiting
  • Sudden changes in speech or vision

Of the above side effects, the most frequent are a rapid or irregular heartbeat, persistent drowsiness and severe vomiting. Contact your doctor if you feel the onset of any of these symptoms.

Can Advil Cold & Sinus cause any gastrointestinal side effects?

Studies show that gastrointestinal (GI) issues are reported by roughly 25% of patients. Typically, these side effects are generally mild. Most gastrointestinal side effects do not extend past slight nausea and abdominal pain. More serious, yet uncommon gastrointestinal symptoms occur in an even smaller percentage of users. They include ulcers, hemorrhages and inflammation of the pancreas and colon.

Evaluate your personal and family medical history to determine whether you are at risk for any gastrointestinal issues, particularly the more unusual and severe side effects. Review this history together with your doctor to find out whether it is safe for you to take Advil Cold & Sinus.

Can Advil Cold & Sinus cause any cardiovascular side effects?

Cardiovascular side effects in Advil Sinus users are rare, occurring in roughly 1-3% of patients. Symptoms include swelling of fingers and toes, high blood pressure and peripheral edema. Research shows that a chief ingredient of Advil Cold & Sinus, pseudoephedrine, may increase the severity of previous hypertension issues. Pseduophedrine may also be responsible for additional cardiovascular side effects such as coronary artery spasm and chest pain.

Find out whether you are predisposed to heart arrhythmias, as Advil Cold & Sinus is known to increase the likelihood of future incidents of arrhythmia in a small percentage of patients.

Can Advil Cold & Sinus have adverse effects on the nervous system?

Studies show that severe side effects on the central nervous system after taking Advil Cold & Sinus are very rare, and include pseduotumor cerebri, meningitis and paresthesias. Milder side effects are the result of the pseudoephedrine ingredient. They include headache, lethargy, and vertigo, but are easily treatable.

Who should not take Advil Cold & Sinus medication?

If you are particularly sensitive to, or have a history of allergic reactions to the active ingredients in Advil Cold & Sinus (ibuprofen, chlorpheniramine or pseudoephedrine) consult first with your doctor before taking it. Those who have recently undergone heart surgery should call a doctor before taking the medication. Pregnant women or women who are breast-feeding should talk to their doctor before taking Advil Cold & Sinus.

Your Safety First

Those with certain medical conditions should avoid taking Advil to treat sinus infections, particularly those who suffer from liver disease, heart disease, severe high blood pressure, Raynaud’s Syndrome, Crohn’s disease, or angioedema syndrome. If you are a smoker, you may also be an increased risk of suffering from both mild and severe side effects.

Note: This article does not contain an exhaustive list of side effects, as every medication includes adverse symptoms that have not yet been reported. Be sure to contact your primary care physician if you experience any abnormal side effects, and report them to the Food and Drug Administration. Call 911 if you have severe side-effects.

Advil Cold and Sinus

Generic Name: ibuprofen, pseudoephedrine hydrochloride
Dosage Form: tablet, coated

Medically reviewed by Drugs.com. Last updated on May 22, 2019.

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ACTIVE INGREDIENTS (IN EACH CAPLET)

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

PURPOSES

Pain reliever/fever reducer

Nasal decongestant

USES

temporarily relieves these symptoms associated with the common cold or flu:

  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • minor body aches and pains

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • in children under 12 years of age
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, or have trouble urinating due to an enlarged prostate gland
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other product that contains pseudoephedrine or any other nasal decongestant
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years of age and over:
    • take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
    • do not use more than 6 caplets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use

OTHER INFORMATION

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.

INACTIVE INGREDIENTS

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

QUESTIONS OR COMMENTS?

Call toll free 1-800-88-ADVIL

PRODUCT PACKAGING

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Advil COLD & SINUS

Non-Drowsy

Ibuprofen 200 mg >> Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine HCl 30 mg >> Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever

20 COATED CAPLETS*

*Oval-Shaped Tablets

Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

For most recent product information, visit www.advil.com

Appearance of the tan Advil Cold & Sinus caplet is a trademark of Wyeth Consumer Healthcare

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

LIFT HERE For More Drug Facts

Advil Cold and Sinus
ibuprofen, pseudoephedrine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
pseudoephedrine hydrochloride (pseudoephedrine) pseudoephedrine hydrochloride 30 mg
Product Characteristics
Color BROWN (butterscotch) Score no score
Shape CAPSULE (oblong) Size 14mm
Flavor Imprint Code Advil;Cold;Sinus
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0180-10 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET, COATED (TABLET) in 1 BLISTER PACK
2 NDC:0573-0180-21 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 10 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019771 09/19/1989

Labeler – Pfizer Consumer Healthcare (828831730)

Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company, Consumer Site 829390975 MANUFACTURE, ANALYSIS

Pfizer Consumer Healthcare

Medical Disclaimer

More about Advil Cold and Sinus (ibuprofen / pseudoephedrine)

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Español
  • 29 Reviews
  • Drug class: upper respiratory combinations
  • FDA Alerts (2)

Consumer resources

  • Advil Cold & Sinus
  • Advil Cold and Sinus Caplets

Professional resources

Other brands: Motrin Childrens Cold

Other Formulations

  • Advil
  • … +10 more

Related treatment guides

  • Sinus Symptoms

Advil Cold and Sinus Side Effects

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • fast, irregular heartbeat
  • feeling faint or lightheaded, falls
  • hallucinations
  • high blood pressure
  • pain, tingling, numbness in the hands or feet
  • severe stomach pain
  • signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose
  • signs and symptoms of a blood clot such as changes in vision; chest pain; severe, sudden headache; trouble speaking; sudden numbness or weakness of the face, arm, or leg
  • trouble passing urine or change in the amount of urine
  • unexplained weight gain or swelling
  • unusually weak or tired
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • anxious
  • bruising
  • constipation or diarrhea
  • headache
  • loss of appetite
  • nausea, vomiting
  • trouble sleeping

Generic Name: ibuprofen and pseudoephedrine (EYE bue pro fen and SOO doe ee FED rin)
Brand Name: Advil Cold & Sinus, Advil Cold and Sinus Liqui-Gel

Medically reviewed by Drugs.com on Mar 27, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Advil Cold & Sinus?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Advil Cold & Sinus is a combination medicine used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Advil Cold & Sinus may also be used for purposes not listed in this medication guide.

Important Information

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Advil Cold & Sinus just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning, especially in older adults.

Do not use Advil Cold & Sinus if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

How should I take Advil Cold & Sinus?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. An overdose of ibuprofen can damage your stomach or intestines.

Take Advil Cold & Sinus with food or milk to lessen stomach upset.

Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.

If you need surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Advil Cold & Sinus is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, stomach pain, diarrhea, ringing in your ears, severe drowsiness, agitation, sweating, coughing up blood, weak or shallow breathing, fainting, or seizure (convulsions).

What should I avoid while taking Advil Cold & Sinus?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking ibuprofen.

Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Ask a doctor or pharmacist before using any other cough, cold, or pain medicine. Many combination medicines contain ibuprofen or pseudoephedrine. Taking certain products together can cause you to get too much of Advil Cold & Sinus.

Advil Cold & Sinus side effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling like you might pass out;

  • fast, pounding, or uneven heartbeat;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • the first sign of any skin rash, no matter how mild;

  • signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems–upper stomach pain, vomiting, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems–little or no urinating, painful or difficult urination, swelling or rapid weight gain, feeling tired or short of breath;

  • nerve problems–fever, headache, neck stiffness, chills, increased sensitivity to light, seizure (convulsions); or

  • severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Advil Cold & Sinus?

Ask your doctor before using Advil Cold & Sinus if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine (Paxil), sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use Advil Cold & Sinus if you are also using any of the following drugs:

  • lithium;

  • methotrexate;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • heart or blood pressure medication, including a diuretic or “water pill”; or

  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 8.01.

Medical Disclaimer

Advil Cold and Sinus (ibuprofen / pseudoephedrine) Drug Interactions

A total of 450 drugs are known to interact with Advil Cold and Sinus (ibuprofen / pseudoephedrine).

  • 83 major drug interactions
  • 350 moderate drug interactions
  • 17 minor drug interactions

Show all medications in the database that may interact with Advil Cold and Sinus (ibuprofen / pseudoephedrine).

Check for interactions

Type in a drug name to check for interactions with Advil Cold and Sinus (ibuprofen / pseudoephedrine).

Most frequently checked interactions

View interaction reports for Advil Cold and Sinus (ibuprofen / pseudoephedrine) and the medicines listed below.

  • Advil (ibuprofen)
  • Aleve (naproxen)
  • Allegra (fexofenadine)
  • Benadryl (diphenhydramine)
  • Claritin (loratadine)
  • Claritin-D (loratadine / pseudoephedrine)
  • clonazepam
  • cyclobenzaprine
  • Flonase (fluticasone nasal)
  • fluticasone nasal
  • gabapentin
  • hydrocodone
  • ibuprofen
  • lisinopril
  • melatonin
  • metformin
  • Mucinex (guaifenesin)
  • Mucinex D (guaifenesin / pseudoephedrine)
  • Mucinex DM (dextromethorphan / guaifenesin)
  • naproxen
  • omeprazole
  • prednisone
  • prednisone
  • tramadol
  • Tylenol (acetaminophen)
  • Vitamin B12 (cyanocobalamin)
  • Vitamin C (ascorbic acid)
  • Vitamin D3 (cholecalciferol)
  • Xanax (alprazolam)
  • Zoloft (sertraline)
  • Zyrtec (cetirizine)

Advil Cold and Sinus (ibuprofen / pseudoephedrine) alcohol/food interactions

There are 3 alcohol/food interactions with Advil Cold and Sinus (ibuprofen / pseudoephedrine)

Advil Cold and Sinus (ibuprofen / pseudoephedrine) disease interactions

There are 19 disease interactions with Advil Cold and Sinus (ibuprofen / pseudoephedrine) which include:

  • asthma
  • fluid retention
  • GI toxicity
  • rash
  • renal toxicities
  • thrombosis
  • cardiovascular disease
  • PKU
  • anemia
  • heart failure
  • hepatotoxicity
  • hyperkalemia
  • hypertension
  • platelet aggregation inhibition
  • GI narrowing
  • PKU
  • BPH
  • diabetes
  • glaucoma
  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Support Group
  • Pricing & Coupons
  • En Español
  • 29 Reviews
  • Drug class: upper respiratory combinations
  • FDA Alerts (2)
  • Sinus Symptoms

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major

Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.

Moderate

Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.

Minor

Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.

Unknown

No interaction information available.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Benadryl and Advil interaction

What is Benadryl? What is Benadryl used for?

Benadryl is a Brand name for an OTC antihistamine drug that contains diphenhydramine as an active ingredient. It is first-generation, “sedating” antihistamine that crosses the blood-brain barrier and blocks H1 receptors in the CNS and periphery nervous system.

Benadryl is used to treat allergy and cold symptoms such as: sneezing; itching, runny nose; hives; rashes; watery eyes; and other symptoms of allergies and the common cold.

Benadryl is also used to suppress coughs, for the treatment of motion sickness, as a sleep inductor, and in some cases to treat mild forms of Parkinson’s disease. Some Benadryl’s OTC preparations may also contain other active ingredients such as: Acetaminophen, added as a pain reliever and fever reducer, Pseudoephedrine or Phenylephrine added as a nasal decongestants.

What is Advil? What is Advil Used for?

Advil is a Brand name for an OTC medicine that contains ibuprofen as an active ingredient. It is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body.

Advil is used as a fever reducer and pain and inflammation reliever for conditions such as toothache, headache, back pain, menstrual cramps, arthritis, or minor injury. Some Benadryl’s OTC preparations may also contain other active ingredients such as: antihistamines Chlorphenamine or Diphenhydramine, decongestants Pseudoephedrine and Phenylephrine.

Can I take Benadryl and Advil together?

Since, there is no significant interaction between ibuprofen and diphenhydramine patients can take them together in recommendable doses for a short period of time. Ibuprofen is pain reliever and fever reducer while Benadryl is good for common cold and allergy symptoms. Together they will work fine.

However some of Advil products such as Advil Cold and Flu, 7-select Advil PM, Advil Cold, Cough & Flu Nighttime, Advil Cold, Cough & Flu Nighttime, Advil PM and Advil Pain & Head Cold Night already contain diphenhydramine in one dosage form with ibuprofen.

So if patients take on of such product in combination with Benadryl, patients may double the dose of antihistamine and increase the risk of side effects such sedation and drowsiness. Also some Benadryl product may contain acetaminophen as an active ingredient.

Taking such products together with Advil may be undesirable to patients with internal bleeding, gastrointestinal ulcers or some liver, kidney or heart disease. That’s why patients should always talk with their doctor and pharmacist first, before they take something on their own.

Also predisposed patients with some health issues, such as hypertension and fluid retention should talk with their doctor or pharmacist first before using this combination. It is known that ibuprofen may cause fluid retention. Antihistamines drugs such as diphenhydramine can also cause fluid retention due to their anticholinergic properties.

If you suffer from hypertension or worse yet you have heart failure, this drug combination can be very dangerous indeed. Age also plays an important factor as well and seniors should avoid this combination.

The table below shows side effects that can be caused by taking Advil and Benadryl. The incidence of these side effects can be much higher if these drugs are overdosed or if products with same active ingredient are taken together:

  • Nausea
  • Vomiting
  • Epigastric pain
  • Rash
  • Edema
  • Tinnitus
  • Sedation
  • Confusion
  • Anticholinergic effects
  • May decrease cognitive function in geriatric patients
  • Xerostomia
  • Pharyngeal and nasal mucosa dryness
  • Thick sputum

Can I take Advil or Benadryl with Alcohol?

Combination of Advil and alcohol can lead to a higher risk of development of gastrointestinal adverse effects, such as nausea, vomiting, abdominal pain, heartburn, and especially of gastrointestinal bleeding. Gastrointestinal bleeding symptoms can be: vomiting blood, diarrhea, and black color of stool. If such side effects happen, patients should immediately discontinue Advil and call their doctor.

Patients with risk factors for gastrointestinal bleeding, such as stomach or duodenal ulcer, gastritis or bleeding should never use Advil with alcohol. Patients with any sort of kidney or liver disease must avoid the combination of ibuprofen and alcohol as it can additionally exacerbate their condition.

In general alcohol should not be taken together with Benadryl. The exact mechanism of interaction is not clear, but it is known that alcohol may potentiate diphenhydramine’s depressive side effect in Central Nervous System and vice versa causing drowsiness and sedation as most common side effects. The tolerability of the sedative effects from person to person is individual.

Some may be able to tolerate one or two drink while there on Benadryl therapy while others may develop side effects immediately after drinking. Since potential side effects on patients are unpredictable, patients are advised to avoid any alcohol while taking Benadryl. Patients who drive or operate machinery and heavy equipment are highly advised to avoid drinking alcohol because of the possible drowsiness.

Special precautions and warnings during Benadryl and Advil administration:

  • Benadryl shouldn’t be used to make a child sleepy.
  • Benadryl should not be given to a child younger than 6 years without medical advice.
  • Before taking diphenhydramine or acetaminophen products, patients should tell their doctor or pharmacist if they are allergic to them or if they have any other allergies. These products may have some inactive ingredients, which can also cause allergic reactions or other side effects.
  • Alcohol may potentiate effects of antihistamines. Patients should limit alcoholic beverages while using Benadryl.
  • Before taking these medications patients should also tell their doctors or pharmacists if they have some health issues in the past such as: breathing problems (asthma or emphysema), high blood pressure, glaucoma, heart problems, kidney disease, liver disease, stomach or intestine problems, seizures, hyperthyroidism, or enlarged prostate.
  • Benadryl can make patients dizzy or drowsy. They should not drive, use machinery, or do any activity that requires alertness.
  • In elderly patients there is a high-risk after administration of Benadryl because they may increase: the risk of falls and incidence of anticholinergic effects (exacerbation of existing lower urinary tract conditions, benign prostatic hyperplasia, and tolerance).
  • In rare cases, Advil can cause a severe skin reaction. Patients should stop taking this medicine and call their doctor immediately if they have skin redness or a spreading rash that causes blistering and peeling.
  • Advil can increase the risk of serious effects on the stomach or intestines, including bleeding, ulcers or perforation. Advil may be more likely to cause stomach bleeding in adults who are older than 60 years. Patients should call their doctor immediately if they have symptoms of bleeding in your stomach or intestines. This includes worsening stomach pain, coughing up blood or vomit that looks like coffee grounds or black, bloody, or tarry stools.
  • Advil may increase the risk of life-threatening cardiovascular issues, including heart attack or stroke. Do not take Advil just before or after having heart bypass surgery. Patients should seek emergency medical help if they exhibit symptoms of cardiovascular issues, such as weakness, chest pain, shortness of breath or problems with vision or balance.

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