Aleve-D Sinus and Headache NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE BAYER HEALTHCARE LLC. FDA Approved 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
FunFoxMeds box
Substance Naproxen Sodium
Route
ORAL
Applications
ANDA076518
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol polysorbate 80 povidone talc titanium dioxide
Strengths
220 mg 200 mg 120 mg
Treats Conditions
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
Pill Appearance
Shape: oval Color: white Imprint: Aleve;D

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0325866569516
UNII
9TN87S3A3C 6V9V2RYJ8N
Packaging

See New Warnings NON-DROWSY ALL DAY STRONG® ALEVE-D® SINUS & HEADACHE Naproxen sodium 220 mg (NSAID) Pseudoephedrine HCl 120 mg extended-release tablets Pain reliever-fever reducer/nasal decongestant 12 HOUR MULTI-SYMPTOM RELIEF OF SINUS PRESSURE HEADACE · SINUS CONGESTION NASAL CONGESTION actual size 1 CAPLET - 12 HOURS 10 CAPLETS CAPSULE-SHAPED TABLETS Aleve D Sinus and Headache label

Package Descriptions
  • See New Warnings NON-DROWSY ALL DAY STRONG® ALEVE-D® SINUS & HEADACHE Naproxen sodium 220 mg (NSAID) Pseudoephedrine HCl 120 mg extended-release tablets Pain reliever-fever reducer/nasal decongestant 12 HOUR MULTI-SYMPTOM RELIEF OF SINUS PRESSURE HEADACE · SINUS CONGESTION NASAL CONGESTION actual size 1 CAPLET - 12 HOURS 10 CAPLETS CAPSULE-SHAPED TABLETS Aleve D Sinus and Headache label

Overview

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

Indications & 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

Dosage & 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 & 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.
Purpose

Purposes Pain reliever/fever reducer Nasal decongestant

Do Not Use

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

When Using

When using this product • take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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

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.

Questions

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)


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