Label: SUDOGEST- chlorpheniramine maleate, pseudoephedrine hcl tablet

  • NDC Code(s): 0904-5351-24, 0904-5351-96
  • Packager: Major Pharmaceuticals
  • 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 21, 2022

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  • Active ingredients (in each tablet)

    Chlorpheniramine maleate 4 mg
    Pseudoephedrine HCl 60 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • nasal congestion
      • sneezing
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
      • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • heart disease
    • high blood pressure
    • diabetes
    • glaucoma
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    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 (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
    • children under 12 years: do not use
  • 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)
    • store in a dry place and protect from light
    • see end flap for expiration date and lot number
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-5351-24

    Maximum Strength
    SudoGest     Sinus & Allergy

    Chlorpheniramine maleate 4 mg
    Pseudoephedrine HCl 60 mg

    4 mg/60 mg

    Antihistamine/Nasal Decongestant

    Runny Nose & Sneezing,
    Itchy, Watery Eyes,
    Sinus Congestion & Pressure

    24 Tablets

    Actual Size

    50844     REV0619K11108

    Distributed by
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152
    Rev. 10/19  M-17
    Re-order No. 235631

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

    Major 44-111

    Major 44-111


  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    chlorpheniramine maleate, pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5351
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code 44;111
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5351-241 in 1 CARTON12/16/1992
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-5351-962 in 1 CARTON12/16/199201/31/2023
    224 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/16/1992
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-5351)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0904-5351)
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