Aprodine

Major Pharmaceuticals

Major 44-178

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient(s)
• Purpose
• Use(s)
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• Aprodine Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient(s)

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Purpose

Nasal decongestant

Antihistamine

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

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.

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

Aprodine Other information

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

• 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?

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

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