TOPCARE NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]

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  • TOPCARE NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]

TOPCARE NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]
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NDC 36800-094-23, 36800-094-47, 36800-094-68, 36800-094-89
Set ID 1a903229-a8c5-40ff-86af-737e77c8feec
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    Phenylephrine HCl 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

    ask a doctor
  • 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?

    1-888-423-0139

  • Principal Display Panel

    COMPARE TO SUDAFED PE® CONGESTION

    ACTIVE INGREDIENT

    NON-DROWSY

    Nasal Decongestant PE

    PHENYLEPHRINE HCl TABLETS, 10 mg

    MAXIMUM STRENGTH

    OUR PHARMACISTS RECOMMEND

    Sinus + Nasal Congestion

    Sinus Pressure

    actual size

    72 TABLETS

    nasal decongestant pe image
  • INGREDIENTS AND APPEARANCE
    TOPCARE NASAL DECONGESTANT PE 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-094
    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:36800-094-2312 in 1 CARTON09/19/200501/31/2022
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:36800-094-471 in 1 CARTON02/03/200907/02/2011
    2150 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:36800-094-686 in 1 CARTON09/13/2005
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:36800-094-893 in 1 CARTON09/12/2005
    46 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/12/2005
    Labeler - Topco Associates LLC (006935977)
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