SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]

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  • SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]

SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]
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NDC 0904-5351-24, 0904-5351-96
Set ID 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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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

    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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 CARTON12/16/1992
    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.832867894MANUFACTURE(0904-5351)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0904-5351)
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