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

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/11

If you are a consumer or patient please visit this version.

  • Active ingredient(s)

    Pseudoephedrine HCl 60 mg

    Triprolidine HCl 2.5 mg

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  • Purpose

    Nasal decongestant

    Antihistamine

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  • Use(s)

    • 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

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  • 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 rug. 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.

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  • 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

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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)

    • see end flap for expiration date and lot number

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  • Inactive ingredients

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

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  • Questions or comments?

    To Report Adverse Drug Event Call: (800) 616-2471

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  • Principal Display Panel

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    MAJOR®

    NDC 0904-0250-24

    Aprodine™

    TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHORIDES

    DECONGESTANT/ANTIHISTAMINE/FIOLM COATED

    TABLETS

    Head Cold & Allergy Medicine Relieves:

    • Nasal Congestion • Runny Nose

    •Sneezing • Itchy, Watery Eyes

    24 TABLETS

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

    50844       REV1110K17808

    Distributed by

    MAJOR PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150 USA                  M-17

    Re-Order No. 700796

    Rev. 11/10

    Product Packaging

    Product Packaging

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  • INGREDIENTS AND APPEARANCE
    APRODINE 
    pseudoephedrine hcl and tripolidine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-0250
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    TRIPROLIDINE HYDROCHLORIDE (TRIPROLIDINE) TRIPROLIDINE HYDROCHLORIDE 2.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code 44;178
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-0250-24 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    2 NDC:0904-0250-59 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/09/1993
    Labeler - Major Pharmaceuticals (191427277)
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