Label: SUDOGEST PE- phenylephrine hcl tablet, film coated

  • NDC Code(s): 0904-5733-49, 0904-5733-73
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL

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 March 10, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 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

    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • difficulty in urination due to enlargement of the 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 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 (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    Non-Drowsy

    NDC 0904-5733-73

    MAJOR®

    Compare to the active ingredient
    in Sudafed PE® Congestion*

    SUDOGEST™ PE
    Phenylephrine HCl, 10 mg each
    NASAL DECONGESTANT

    Does not contain Pseudoephedrine

    ■ Nasal & Sinus Congestion
    ■ Sinus Pressure

    1 Pill Per Dose

    36 TABLETS
    10 mg each

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
    IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark
    Sudafed PE® Congestion.      50844      REV0118K45307

    Distributed by
    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152 USA
    Rev. 03/18                  M-17
    Re-order No. 100112

    Major 44-453

    Major 44-453

  • INGREDIENTS AND APPEARANCE
    SUDOGEST PE 
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5733
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5733-732 in 1 CARTON01/14/200511/26/2022
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-5733-491 in 1 CARTON01/14/200505/31/2021
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/14/200511/26/2022
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0904-5733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0904-5733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0904-5733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(0904-5733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0904-5733)