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Naproxen Sodium, Pseudoephedrine Hydrochloride

FDA Drug Information • Also known as: Aleve-D Sinus And Headache, Sinus And Cold D

Brand Names
Aleve-D Sinus And Headache, Sinus And Cold D
Route
ORAL
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Product Type
HUMAN OTC DRUG

What Is Naproxen Sodium, Pseudoephedrine Hydrochloride Used For?

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

    • Dosage and Administration

    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 every 12 hours; do not take more than 2 caplets in 24 hours
  • children under 12 years: do not use

    • Warnings and Precautions

    Warnings 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 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 (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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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
  • 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, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug When using this product
  • take with food or milk if stomach upset occurs 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
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • 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 in your throat
  • 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 at 20...

    • About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.