SMART SENSE SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [KMART CORPORATION]

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  • SMART SENSE SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [KMART CORPORATION]

SMART SENSE SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [KMART CORPORATION]
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NDC 49738-936-80
Set ID 4e472e39-a5ea-4e65-bcb9-6cc6ecf0b232
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each caplet) – SINUS RELIEF Day

    Acetaminophen 325 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Active ingredients (in each caplet) – SINUS RELIEF Night

    Acetaminophen 325 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 5 mg

  • Purposes – SINUS RELIEF Day

    Pain reliever

    Expectorant

    Nasal decongestant

  • Purposes – SINUS RELIEF Night

    Pain reliever

    Antihistamine

    Nasal decongestant

  • Uses

    •
    temporarily relieves:
    •
    nasal congestion
    •
    headache
    •
    minor aches and pains
    •
    sinus congestion and pressure
    •
    runny nose and sneezing (SINUS RELIEF Night only)
    •
    temporarily promotes nasal and/or sinus drainage
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS RELIEF Day only)
  • Warnings

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day while using these products

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    •
    skin reddening
    •
    blisters
    •
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

  • Do not use

    •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    •
    with any other product containing diphenhydramine, even one used on skin (SINUS RELIEF Night only)
    •
    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 these products.
    •
    if you have ever had an allergic reaction to these products or any of their ingredients
  • Ask a doctor before use if you have

    •
    liver disease
    •
    heart disease
    •
    diabetes
    •
    high blood pressure
    •
    thyroid disease
    •
    trouble urinating due to an enlarged prostate gland
    •
    glaucoma (SINUS RELIEF Night only)
    •
    a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only)
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only)
    •
    cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only)
  • Ask a doctor or pharmacist before use if you are

    •
    taking the blood thinning drug warfarin
    •
    taking sedatives or tranquilizers (SINUS RELIEF Night only)
  • When using these products

    •
    do not use more than directed
    •
    excitability may occur, especially in children (SINUS RELIEF Night only)
    •
    marked drowsiness may occur (SINUS RELIEF Night only)
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS RELIEF Night only)
    •
    avoid alcoholic drinks (SINUS RELIEF Night only)
    •
    be careful when driving a motor vehicle or operating machinery (SINUS RELIEF Night only)
  • Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    pain, cough or nasal congestion gets worse or lasts more than 7 days
    •
    fever gets worse or lasts more than 3 days
    •
    redness or swelling is present
    •
    new symptoms occur
    •
    cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only)
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not take more than directed (see Overdose warning)
    •
    do not take more than 10 caplets in any 24-hour period
    •
    adults and children 12 years of age and older: take 2 caplets every 4 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    each caplet contains: sodium 4 mg (SINUS RELIEF Day only)
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients - SINUS RELIEF Day only

    croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Inactive ingredients - SINUS RELIEF Night only

    crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    SEE NEW WARNINGS

    COMPARE TO ACTIVE INGREDIENTS IN MUCINEX® SINUS-MAX®

    ACTUAL SIZE

    daytime

    sinus relief

    ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCl

    PAIN RELIEVER, EXPECTORANT, NASAL DECONGESTANT

    MAXIMUM STRENGTH

    10 CAPLETS

    RELIEVES:

    SINUS PRESSURE

    HEADACHE – CONGESTION

    THINS & LOOSENS MUCUS

    nighttime

    sinus relief

    ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

    PAIN RELIEVER, ANTIHISTAMINE, NASAL DECONGESTANT

    MAXIMUM STRENGTH

    RELIEVES:

    NASAL CONGESTION

    SINUS PRESSURE & PAIN

    RUNNY NOSE – SNEEZING

    10 CAPLETS

    Smart Sense Sinus Relief Image 1
    Smart Sense Sinus Relief Image 2
  • INGREDIENTS AND APPEARANCE
    SMART SENSE SINUS RELIEF 
    acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-936
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-936-801 in 1 KIT; Type 0: Not a Combination Product12/29/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 BLISTER PACK 10 
    Part 25 BLISTER PACK 10 
    Part 1 of 2
    SMART SENSE DAYTIME SINUS RELIEF 
    acetaminophen, guaifenesin, phenylephrine hcl capsule, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code L145
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/29/2015
    Part 2 of 2
    SMART SENSE NIGHTTIME SINUS RELIEF 
    acetaminophen, diphenhydramine hcl, phenylephrine hcl capsule, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code L625
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/29/2015
    Labeler - Kmart Corporation (008965873)
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