Label: PSEUDOEPHEDRINE HYDROCHLORIDE tablet

  • 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 December 13, 2022

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  • Drug Facts

    Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • 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

    • take every 4-6 hours
    • do not take more than 4 doses in 24 hours

    adults & children 12 years & over

    2 tablets

    children 6 to under 12 years

    1 tablets

    children under 6 years

    do not use

  • Other information

    • Store between 15° - 30°C (59° - 86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

  • Questions or comments?

    1-800-616-2471

  • 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

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed®.

  • PRINCIPAL DISPLAY PANEL

    MAJOR ®

    NDC 0904-6727-60

    Non Drowsy SudoGest TM

    Nasal Decongestant

    Pseudoephedrine Hydrochloride 30mg

    FOR PHARMACY USE ONLY.

    NOT FOR RETAIL SALE.

    Relieves Nasal and Sinus Congestion due to Colds or Hay Fever without drowsiness

    Compare to the active ingredient in Sudafed® Sinus Congestion*

    100 Tablets

    Major Label

  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6727
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 1004
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6727-60100 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/31/2019
    Labeler - Major Pharmaceuticals (191427277)
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