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 April 14, 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)
    • 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

  • HOW SUPPLIED

    Product: 50090-0155

    NDC: 50090-0155-1 30 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-0155-3 12 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-0155-4 20 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-0155-5 15 TABLET, FILM COATED in a BOTTLE

  • Pseudoephedrine Hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0155(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)  
    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:50090-0155-130 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    2NDC:50090-0155-312 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    3NDC:50090-0155-420 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    4NDC:50090-0155-515 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    5NDC:50090-0155-024 in 1 BOTTLE; Type 0: Not a Combination Product10/01/201810/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/07/1984
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0155) , REPACK(50090-0155)
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