SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]

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SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]
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NDC 50436-0333-2
Set ID 9044cb58-0386-44a8-ba27-bd205aa99fb4
Category HUMAN OTC DRUG LABEL
Packager Unit Dose Services
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

  • HOW SUPPLIED

    Product: 50436-0333

    NDC: 50436-0333-2 24 TABLET, FILM COATED in a BOTTLE

  • SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-0333(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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 44;113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50436-0333-2 24 in 1 BOTTLE; 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 - Unit Dose Services (831995316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose Services831995316REPACK(50436-0333) , RELABEL(50436-0333)
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