SUNMARK SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [MCKESSON]

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  • SUNMARK SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [MCKESSON]

SUNMARK SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [MCKESSON]
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NDC 49348-393-01
Set ID c09e8374-aa5c-4a0d-9073-58bf63a2e201
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA076518
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  • 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 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

    sinus & cold-D

    Naproxen sodium 220 mg

    Pseudoephedrine hydrochloride 120 mg

    Extended-release tablet

    Pain reliever/Fever reducer (NSAID)

    Nasal decongestant

    12-hour multi-symptom relief of Sinus pressure, Headache, Sinus congestion, Nasal congestion & Body aches

    1 Caplet - 12 hours

    NON-DROWSY

    Actual Size

    GLUTEN FREE

    10 CAPLETS**

    **Capsule-Shaped Tablets

    sinus and cold D image 1
    sinus and cold D image 2
  • INGREDIENTS AND APPEARANCE
    SUNMARK SINUS AND COLD D 
    naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-393
    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:49348-393-0110 in 1 CARTON08/15/201312/31/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07651808/15/201312/31/2021
    Labeler - Strategic Sourcing Services LLC (116956644)
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