Aleve cold and sinus

Aleve D Sinus and Cold Naproxen 220 mg/Pseudoephedrine HCL120 mg Caplets

Allergy Alert: Naproxen sodium 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed. Do not use 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; in children under 12 years of age. Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers; stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain; ulcers; asthma; bleeding problems; high blood pressure; heart or kidney disease; taken a diuretic; reached age 60 or older; thyroid disease; diabetes; trouble urinating due to an enlarged prostate gland. Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription); taking a blood thinning (anticoagulant) or steroid drug; under a doctor’s care for any serious condition; using any other product that contains naproxen or pseudoephedrine; taking any other pain reliever/fever reducer or nasal decongestant; 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 feel faint, vomit blood, or have bloody or black stools (These are signs of stomach bleeding); fever gets worse or lasts more than 3 days; stomach pain or upset gets worse or lasts; redness or swelling is present in the painful area; any new symptoms appear; you have difficulty swallowing or the caplet feels stuck in your throat; you develop heartburn; you get nervous, dizzy, or sleepless, nasal congestion lasts more than 7 days. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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. Do not use if the blister seal is cut or broken.

Drug Facts

Drug Facts

Otc – Active Ingredient

Active ingredients(in each caplet)Naproxen sodium 220 mg(naproxen 200 mg) (NSAID)*Pseudoephedrine HCl 120 mg, extended-release*nonsteroidal anti-inflammatory drug

Otc – Purpose

PurposesPain reliever/fever reducerNasal decongestant

Uses

Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus
drainage and restores freer breathing through the nose) • fever

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic
reaction, especially in people allergic to aspirin. Symptomsmay include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blistersIf an allergic reaction occurs, stop use and seek medical helpright away.Stomach bleeding warning: This product contains an NSAID,
which may cause severe stomach bleeding. The chance ishigher 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 nonprescriptionNSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while usingthis product • take more or for a longer time than directed

Otc – Do Not Use

Do not use• if you have ever had an allergic reaction to any other painreliever/fever reducer• right before or after heart surgery• if you are now taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric,or emotional conditions, or Parkinson’s disease), or for2 weeks after stopping the MAOI drug. If you do not know ifyour prescription drug contains an MAOI, ask a doctor orpharmacist before taking this product.• in children under 12 years of age

Otc – Ask Doctor

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

Otc – Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are• under a doctor’s care for any serious condition• taking any other drug

Otc – When Using

When using this product• take with food or milk if stomach upset occurs• the risk of heart attack or stroke may increase if youuse more than directed or for longer than directed

Otc – Stop Use

Stop use and ask a doctor if• you experience any of the following signs of stomachbleeding:• feel faint • vomit blood • have bloody or black stools• have stomach pain that does not get better• redness or swelling is present in the painful area• any new symptoms appear• fever gets worse or lasts more than 3 days• you have difficulty swallowing or the caplet feels stuck inyour throat• you get nervous, dizzy, or sleepless• nasal congestion lasts more than 7 days

Otc – Pregnancy Or Breast Feeding

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

Otc – Keep Out Of Reach Of Children

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

Directions

Directions •
do not take more than directed•
the smallest effective dose should be used•
swallow whole; do not crush or chew •
drink a full glass of water with each dose• adults and children 12 years and older
: 1 caplet every12 hours; do not take more than 2 caplets in 24 hours • children under 12 years: do not use

Other Information

Other information•
each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F) • store in a dry place

Inactive Ingredient

Inactive ingredients colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polysorbate 80,povidone, talc, titanium dioxide

Otc – Questions

Questions or comments? 1-800-986-0369

Aleve-D Cold And Sinus

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen 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).

Naproxen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, headache, fever, and minor aches and pains caused by the common cold or flu.

Naproxen and pseudoephedrine may also be used for purposes not listed in this medication guide.

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

Naproxen 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 this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen, especially in older adults.

Naproxen 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. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen and pseudoephedrine, especially in older adults.

You should not use this medicine if you are allergic to naproxen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • asthma;
  • a thyroid disorder;
  • enlarged prostate, urination problems;
  • liver or kidney disease; or
  • fluid retention.

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Do not use naproxen and pseudoephedrine without a doctor’s advice if you are pregnant.

Naproxen can pass into breast milk and may harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Naproxen and pseudoephedrine is not approved for use by anyone younger than 12 years old.

Aleve-D Sinus & Cold Side Effects

Generic Name: naproxen / pseudoephedrine

Medically reviewed by Drugs.com. Last updated on May 13, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Interactions
  • Pregnancy
  • Reviews
  • More

Note: This document contains side effect information about naproxen / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Aleve-D Sinus & Cold.

For the Consumer

Applies to naproxen / pseudoephedrine: oral tablet extended release 12 hour

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure.
  • Very bad dizziness or passing out.
  • Any unexplained bruising or bleeding.
  • Very bad belly pain.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to naproxen/pseudoephedrine: oral tablet extended release

General

The manufacturer has not provided adverse event information.

1. “Product Information. Aleve-D Sinus & Cold (naproxen-pseudoephedrine).” Bayer Pharmaceutical Inc, West Haven, CT.

Further information

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

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about Aleve-D Sinus & Cold (naproxen / pseudoephedrine)

  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • En Español
  • 2 Reviews
  • Drug class: upper respiratory combinations
  • FDA Alerts (1)

Consumer resources

  • Aleve Cold and Sinus
  • Aleve-D Sinus & Cold

Other brands: Aleve-D Sinus & Headache, Sudafed 12 Hour Pressure+Pain

Other Formulations

  • Aleve

Related treatment guides

  • Nasal Congestion
  • Pain/Fever
  • Sinus Symptoms

Advil Allergy & Congestion Relief Coated Tablets20 ea

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.

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 because this product contains too much medication for children under this 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

  • You have a breathing problem such as emphysema or chronic bronchitis
  • 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, glaucoma 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 sedatives or tranquilizers
  • Taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine
  • 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
  • Avoid alcoholic drinks
  • Be careful when driving a motor vehicle or operating machinery
  • Drowsiness may occur
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • May cause excitability especially in children

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
  • Pain gets worse or lasts more than 7 days
  • Fever gets worse or lasts more than 3 days
  • Nasal congestion lasts for more than 7 days
  • Redness or swelling is present in the painful area
  • You get nervous, dizzy, or sleepless
  • Symptoms continue or get worse
  • 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..

If you have a runny nose and run to the store to purchase a decongestant, don’t be too surprised if a detective shows up at your door shortly thereafter. Ever since a federal law went into effect that regulates pseudoephedrine, tracking systems have begun to pop up in local pharmacies, reports the Associated Press Since the law went into effect in 2006, pseudoephedrine, a key ingredient in the manufacture of methamphetamine, has migrated behind the counter at pharmacies. Customers must show photo ID to buy the decongestant, and the legal limit for purchases is 9 grams per month – roughly the equivalent of two 15-dose boxes of 24-hour Claritin D, or three 10-dose boxes of Aleve Cold & Sinus, or six 24-dose boxes of Sudafed.

Tracking systems such as MethCheck send local law enforcement the buyer’s name, address and age with a swipe of a driver’s license or state-issued ID card. If a customer is on a list of suspicious persons or he buys more than the legal limit of 9 grams per month, a detective is notified via email.

MethCheck will soon be able to track purchases by neighborhood or street, which would locate areas where meth chemists enlists others in the neighborhood to buy pseudoephedrine. MethCheck will be used at some 7,000 pharmacies in 43 states by next year, said Rick Jones, spokesman for Louisville-based Appriss Inc., which developed MethCheck.

Critics of the tracking software have raised concerns that people with colds or allergies could be suspected of meth production just for buying more than the average amount of cold medicine.

“People’s health information – it’s intimate, it’s personal, it’s something people desperately want to keep private,” said Beth Wilson, executive director of the American Civil Liberties Union in Kentucky. “For law enforcement to do an investigation, there must be a reasonable suspicion. I’m not sure just the amount of medication justifies that.”

Law enforcement counters by saying that the type of evidence from MethCheck only leads to preliminary interviews with police and is not enough to warrant an arrest.

“It’s just an investigative tool,” said Van Ingram of the Kentucky Office of Drug Control Policy. “During the course of any investigation, you’re sometimes going to interview people who aren’t guilty of wrongdoing but who are part of the investigative process.”

From a Fourth Amendment perspective, there would be nothing wrong with this if the pharmacy customer is truly free to decline the conversation. But if police are authorized to insist or to impede a person’s free movement (or take her into custody), there must at least be reasonable suspicion that the person has committed a crime. Does buying too much Sudafed (perhaps because it’s on sale) qualify?

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