APRODINE- pseudoephedrine hcl and tripolidine tablet, film coated 
Proficient Rx LP

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.

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Major 44-178

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
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)

Revised: 10/2019
Document Id: fd421f26-c475-4559-af71-62c1d91f5927
Set id: dbd8e15e-7bb0-46b5-9d69-3f8ffaf3bfda
Version: 3
Effective Time: 20191001
 
Proficient Rx LP