Naproxen sodium and Pseudoephedrine Hydrochloride

FDA Drug Profile — Sudafed Sinus 12 Hour Pressure plus Pain

Drug Details

Generic Name
Naproxen sodium and Pseudoephedrine Hydrochloride
Brand Names
Sudafed Sinus 12 Hour Pressure plus Pain
Application Number
ANDA076518
Sponsor
Kenvue Brands LLC
NDC Codes
1
Dosage Forms
TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE

Indications and Usage

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

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.