SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]

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SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]
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NDC 0904-5125-46, 0904-5125-59
Set ID cfb1e96c-0580-ca73-70e4-75e07140ad43
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
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)
    • use by expiration date on package
  • 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 0904-5125-46

    MAJOR®

    SudoGest™
    NASAL DECONGESTANT  60 mg
    Pseudoephedrine Hydrochloride 60 mg

    Relieves Nasal and Sinus Congestion due to Colds or Hay Fever
    Without Drowsiness

    30 TABLETS

    Actual Size

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

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

    50844  REV0712G11301

    Major 44-113

    Major 44-113


  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 44;113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5125-591 in 1 CARTON12/07/198411/26/2021
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0904-5125-4630 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/1984
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/07/1984
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0904-5125)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0904-5125)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0904-5125)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(0904-5125)
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