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

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 1, 2019

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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 or other upper respiratory allergies:
    •
    runny nose
    •
    itchy, watery eyes
    •
    sneezing
    •
    itching of the nose or throat
    •
    temporarily relieves nasal congestion due to the common cold 
  • 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
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    •
    do not exceed recommended dose
    •
    excitability may occur, especially in children
    •
    drowsiness may occur
    •
    avoid alcoholic drinks
    •
    alcohol, sedatives and tranquilizers may increase drowsiness
    •
    be careful 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 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 this product in children under 12 years of age 
  • Other information

    •
    store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    •
    see end flap for expiration date and lot number 
  • Inactive ingredients

    corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica gel, stearic acid, titanium dioxide

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 71205-100-24

    Aprodine™
    TABLETS

    TRIPROLIDINE HCl AND PSEUDOEPHEDRINE HCl
    DECONGESTANT/ANTIHISTAMINE/FILM COATED

    Head Cold & Allergy Medicine

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

    24 TABLETS

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

    50844                 REV0612M17808
    Distributed by
    MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150 USA           M-17

    Relabeled by
    Proficient Rx LP
    Thousand Oaks, CA 91320
    Re-Order No. 700796
    Rev. 09/13

    71205-100-24
  • INGREDIENTS AND APPEARANCE
    APRODINE 
    pseudoephedrine hcl and tripolidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-100(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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code 44;178
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-100-241 in 1 CARTON09/04/2018
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/09/1993
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-100)
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