Label: APRODINE- pseudoephedrine hcl and triprolidine hcl tablet, film coated

  • NDC Code(s): 0904-0250-24, 0904-0250-59
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • Active ingredients (in each tablet)

    Pseudoephedrine HCl 60 mg
    Triprolidine HCl 2.5 mg

  • Purpose

    Nasal decongestant
    Antihistamine

  • 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
      • nasal congestion
  • 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

    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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
    • excitability may occur, especially in children
    • use caution when driving a motor vehicle or operating machinery
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness

    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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-0250-24

    Maximum Strength
    Aprodine™     Tablets

    Pseudoephedrine HCl 60 mg
    Triprolidine HCl 2.5 mg

    60 mg/2.5 mg

    Nasal Decongestant/Antihistamine

    Relieves Nasal Congestion,
    Sneezing, Runny Nose,
    Itchy, Watery Eyes

    Actual Size

    24 Tablets

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

    50844            REV0719N17808

    Distributed by:
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152

    Rev. 11/19      M-17
    Re-order No. 700796

    Major 44-178

    Major 44-178

  • INGREDIENTS AND APPEARANCE
    APRODINE 
    pseudoephedrine hcl and triprolidine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code 44;178
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-0250-241 in 1 CARTON01/09/199305/05/2024
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-0250-591 in 1 CARTON01/09/199305/05/2024
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/09/199305/05/2024
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0904-0250)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-0250)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0904-0250)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0904-0250)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0904-0250)
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