Label: ALEVE-D SINUS AND HEADACHE- naproxen sodium, pseudoephedrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 6, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (in each caplet)

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    Pseudoephedrine HCl 120 mg,

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Nasal decongestant

  • 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

  • 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.

  • 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

  • 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,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 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

  • WHEN USING

    When using this product

    • take with food or milk if stomach upset occurs

  • STOP USE

    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

  • PREGNANCY OR BREAST FEEDING

    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

    Keep out of reach of children. In case of overdose, get

    medical help or contact a Poison Control Center right away.

  • 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

  • Other Information

    Other information

    each caplet contains: sodium 21 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

  • QUESTIONS

    Questions or comments?

    1-800-986-0369

    (Mon – Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    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

  • INGREDIENTS AND APPEARANCE
    ALEVE-D SINUS AND HEADACHE 
    naproxen sodium, pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6045
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Oblong) Size17mm
    FlavorImprint Code Aleve;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-6045-101 in 1 CARTON01/01/2014
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07651801/01/2014
    Labeler - Bayer HealthCare LLC. (112117283)