Label: PSEUDOEPHEDRINE HYDROCHLORIDE tablet

  • NDC Code(s): 0904-6728-46, 0904-6728-52, 0904-6907-06
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 6, 2024

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  • Drug Facts

    Active ingredient (in each tablet)

    Pseudoephedrine HCl 60 mg

  • PURPOSE

    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 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.

  • 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 in a dry place at 15° – 30°C (59° – 86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

  • Questions or comments?

    (800) 231-4670

  • SPL UNCLASSIFIED SECTION

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

    DISTRIBUTED BY: MAJOR® PHARMACEUTICALS
    INDIANAPOLIS, IN 46268
    www.majorpharmaceuticals.com

  • PRINCIPAL DISPLAY PANEL

    MAJOR

    NDC 0904-6728-46

    SudoGest TM

    Nasal Decongestant

    Pseudoephedrine Hydrochloride 60 mg

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

    30 Tablets

    Major Label

    Major Label

  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6728
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code CPC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6728-521 in 1 CARTON08/26/2019
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0904-6728-4630 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/26/2019
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6907
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code CPC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6907-065 in 1 BOX04/11/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/31/2019
    Labeler - Major Pharmaceuticals (191427277)
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