Label: SUDOGEST NASAL DECONGESTANT- 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 February 6, 2023

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  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves sinus congestion and pressure
    •
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    symptoms do not improve within 7 days or occur with a 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 (1-800-222-1222).

  • Directions

    adults and children 12 years and over
    •
    take 2 tablets every 4 to 6 hours
    •
    do not take more than 8 tablets in 24 hours

    children ages 6 to 11 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

    •
    each tablet contains: calcium 20 mg
    •
    store at 20°-25°C (68°-77°F)
    •
    do not use if blister unit is broken or torn
  • Inactive ingredients

    carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

  • Questions or comments?

    1-800-616-2471

  • HOW SUPPLIED

    Product: 50090-4345

    NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON

    NDC: 50090-4345-0 48 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-4345-2 12 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-4345-3 30 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-4345-4 4 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-4345-5 15 TABLET, FILM COATED in a BOTTLE

  • Pseudoephedrine HCl

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUDOGEST NASAL DECONGESTANT 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4345(NDC:0904-6337)
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUND (convex) Size7mm
    FlavorImprint Code L432
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-4345-124 in 1 CARTON06/10/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50090-4345-212 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
    3NDC:50090-4345-515 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
    4NDC:50090-4345-330 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
    5NDC:50090-4345-44 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
    6NDC:50090-4345-048 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/10/1991
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4345)
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