SUNMARK NASAL DECONGESTANT PE MAXIMUM STRENGTH (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]

SUNMARK NASAL DECONGESTANT PE MAXIMUM STRENGTH (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]
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NDC 49348-700-07, 49348-700-48
Set ID 140dec71-7933-4d38-870a-9233061222c8
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredient (in each tablet)

    Phenylephrine HCI 10 mg

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves sinus congestion and pressure
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • Warnings

    Do not use

    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.

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    nervousness, dizziness, or sleeplessness occur
    symptoms do not improve within 7 days or occur with a fever

    If pregnant or breast-feeding,

    ask a health professional before use.

    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

    adults and children 12 years and over

    take 1 tablet every 4 hours
    do not take more than 6 tablets in 24 hours

    children under 12 years

    do not use this product in children under 12 years of age

  • Other information

    store at 20-25°C (68-77°F)
    do not use if blister unit is broken or torn
  • Inactive ingredients

    anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO SUDAFED PE® CONGESTION

    ACTIVE INGREDIENT

    nasal decongestant PE

    Maximum Strength

    Phenylephrine HCl Tablets, 10 mg

    Nasal & sinus congestion - Sinus pressure

    36 doses - 1 pill/dose

    GLUTEN FREE

    NON-DROWSY

    Actual Size

    36 TABLETS 10 mg EACH

    nasal decongestant pe image
  • INGREDIENTS AND APPEARANCE
    SUNMARK NASAL DECONGESTANT PE  MAXIMUM STRENGTH
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-700-481 in 1 CARTON02/14/2005
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49348-700-072 in 1 CARTON02/14/2005
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/14/2005
    Labeler - Strategic Sourcing Services LLC (116956644)