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Aprodine by Major Pharmaceuticals

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg, TRIPROLIDINE HYDROCHLORIDE 2.5mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-0250

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Major 44-178

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

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

Product Packaging

APRODINE 
pseudoephedrine hcl and tripolidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0250
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
TRIPROLIDINE HYDROCHLORIDE (TRIPROLIDINE) TRIPROLIDINE HYDROCHLORIDE2.5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code44;178
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-0250-241 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
124 TABLET, FILM COATED (24 TABLET) in 1 BLISTER PACK
2NDC:0904-0250-591 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
2100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/09/1993
Labeler - Major Pharmaceuticals (191427277)

Revised: 07/2011
 
Major Pharmaceuticals

← See all Aprodine brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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