Label: SUDOGEST- pseudoephedrine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 1, 2019

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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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