Label: SUDOGEST- pseudoephedrine hydrochloride 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 January 1, 2021

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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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