SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]

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SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]
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NDC 63187-541-15, 63187-541-30, 63187-541-60, 63187-541-90
Set ID 52ab64d7-b4c8-45d1-8e45-271f4dda1420
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 60 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

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

    When using this product

    do not exceed recommended dose.

    Stop use and ask a doctor if

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

    If pregrant 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 older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

  • Questions or comments?

    (800)-616-2471

  • Principal display panel

    FOR PHARMACY USE ONLY.
    NOT FOR RETAIL SALE.

    NDC 63187-541-30

    SudoGest™
    NASAL DECONGESTANT  60 mg
    Pseudoephedrine Hydrochloride 60 mg
    Relieves Nasal and Sinus Congestion due to Colds or Hay Fever
    Without Drowsiness

    30 TABLETS

    Distributed by MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150 USA   Rev. 02/13    M-17
    50844  REV0712N11312

    Repackaged by Proficient Rx LP
    Thousand Oaks, CA 91320

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    63187-541-30

    Major 44-113

  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-541(NDC:0904-5125)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 44;113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-541-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
    2NDC:63187-541-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
    3NDC:63187-541-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
    4NDC:63187-541-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/1994
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-541) , RELABEL(63187-541)
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