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

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SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PROFICIENT RX LP]
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NDC 71205-133-24
Set ID 654a0b48-1461-4d4d-be0a-f821bb1a931d
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 30 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 2 for 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
    •
    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 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 older

    take 2 tablets every 4 to
    6 hours; do not take
    more than 8 tablets in 24
    hours

    children ages
    6 to 12 years

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

    children under
    6 years

    do not use this product
    in children under 6 years
    of age
  • Other information

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

    croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    NDC 7105-133-24
    *Compare to the active ingredient in Sudafed® Congestion

    FOR PHARMACY USE ONLY.
    NOT FOR RETAIL SALE.

    Non-Drowsy

    SudoGest™
    NASAL DECONGESTANT
    Pseudoephedrine Hydrochloride 30 mg
    Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

    24 TABLETS

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

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
    50844         REV0712L11212

    Distributed by
    MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150 USA          M-17
    Rev. 08/13
    Re-Order No. 700321

    Relabeled By;
    Proficient Rx LP
    Thousand Oaks CA 91320

    71205-133-24
  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-133(NDC:0904-5053)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-133-241 in 1 CARTON10/01/2018
    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 finalpart34108/25/1981
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-133)
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