major 44-287a

major 44-287a
SPL v6
SPL
SPL Set ID 6612e514-2690-4f5b-8a82-0e54d362758f
Route
oral
Published
Effective Date 2025-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (60 mg) triprolidine (2.5 mg)
Inactive Ingredients
hypromellose, unspecified magnesium stearate polyethylene glycol, unspecified microcrystalline cellulose silicon dioxide titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 287 Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-11-11

Purpose

Nasal decongestant Antihistamine

Description

Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg


Medication Information

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
Purpose

Nasal decongestant

Antihistamine

Directions
  • do not take more than directed

  • 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

hypromellose, magnesium stearate, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide

Description

Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg

Principal Display Panel

MAJOR®

NDC 0904-7302-60

maximum strength

Aprodine™ tablets

pseudoephedrine HCl 60 mg

nasal decongestant

triprolidine HCl 2.5 mg

antihistamine

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

relieves: • nasal congestion • sneezing • runny nose • itchy, watery eyes

actual size 

100 tablets

50844 REV1123A28712

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Major 44-287A
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.

Questions Or Comments?

1-800-426-9391

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 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.

Active Ingredients (in Each Tablet)

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

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.


Structured Label Content

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
Purpose

Nasal decongestant

Antihistamine

Directions
  • do not take more than directed

  • 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 (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 (Inactive ingredients)

hypromellose, magnesium stearate, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide

Principal Display Panel (Principal display panel)

MAJOR®

NDC 0904-7302-60

maximum strength

Aprodine™ tablets

pseudoephedrine HCl 60 mg

nasal decongestant

triprolidine HCl 2.5 mg

antihistamine

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

relieves: • nasal congestion • sneezing • runny nose • itchy, watery eyes

actual size 

100 tablets

50844 REV1123A28712

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Major 44-287A
Do Not Use (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.

Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (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 (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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