SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC]

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SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC]
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NDC 55319-453-08
Set ID c11c4469-8ac9-4615-a7b3-4f2c812c045c
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc
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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
  • 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
    • diabetes
    • thyroid disease
    • high blood pressure
    • difficulty in urination due to enlargement of the 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 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.

  • 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    FAMILY
    wellness™

    COMPARE TO THE ACTIVE INGREDIENT OF
    SUDAFED PE® SINUS CONGESTION*

    MAXIMUM STRENGTH
    Suphedrine PE

    Phenylephrine HCl 10 mg
    Nasal Decongestant
    • Sinus Pressure
    • Congestion

    NON-DROWSY

    24 TABLETS

    Actual
    Size

    100% SATISFACTION
    GUARANTEED
    OR YOUR MONEY BACK

    TAMPER EVIDENT: DO NOT USE
    IF PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Sudafed PE® Sinus Congestion.
    50844       REV0820G45308

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

    NOT 100% SATISFIED?
    Return package and unused product within 30 days to any
    Family Dollar store for a refund (with receipt) or exchange.

    Family Wellness 44-453

    Family Wellness 44-453

  • INGREDIENTS AND APPEARANCE
    SUPHEDRINE PE 
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-453
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-453-081 in 1 CARTON01/14/2005
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/14/2005
    Labeler - Family Dollar Services Inc (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(55319-453)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(55319-453)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(55319-453)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(55319-453)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(55319-453)
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