Label: ALL DAY SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release

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

Drug Label Information

Updated August 25, 2020

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

  • Active ingredients (in each caplet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

    Pseudoephedrine HCl 120 mg, extended-release

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer

    Nasal decongestant

  • 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.

    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 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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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

    each caplet contains: sodium 21 mg
    meets USP Dissolution Test 2
    store at 20-25°C (68-77°F)
    store in a dry place
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

    Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Aleve-D® Sinus & Cold active ingredients

    NON-DROWSY

    All Day Sinus & Cold D

    NAPROXEN SODIUM 220 mg / PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg EXTENDED-RELEASE TABLET

    PAIN RELIEVER / FEVER REDUCER (NSAID) & NASAL DECONGESTANT

    12 HOUR

    12-hour multi-symptom relief of sinus pressure, headache, sinus congestion, nasal congestion & body aches

    1 caplet – 12 hours

    ACTUAL SIZE

    20 CAPLETS** (**Capsule-Shaped Tablets)

    417-94-all-day-sinus-and-cold-d-1
    417-94-all-day-sinus-and-cold-d-2
  • INGREDIENTS AND APPEARANCE
    ALL DAY SINUS AND COLD D 
    naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0650
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code L417
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0650-0120 in 1 CARTON05/23/2013
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07651805/23/2013
    Labeler - Walgreen Company (008965063)