naproxen sodium, pseudeoephedrine hydrochloride

FDA Drug Profile — Aleve-D Sinus and Cold

Drug Details

Generic Name
naproxen sodium, pseudeoephedrine hydrochloride
Brand Names
Aleve-D Sinus and Cold
Application Number
ANDA076518
Sponsor
Bayer HealthCare LLC.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE

Indications and Usage

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. 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.