APRODINE- pseudoephedrine hcl and tripolidine tablet, film coated 
Rebel Distributors Corp

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.

----------

Aprodine

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

Aprodine 60mg/2.5mg

APRODINE 
pseudoephedrine hcl and tripolidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-929(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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;178
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-929-6060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/09/1993
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 8/2011
Document Id: e5e84aa0-a99d-47ae-983b-fc03f0f2c754
Set id: e5e84aa0-a99d-47ae-983b-fc03f0f2c754
Version: 1
Effective Time: 20110810
 
Rebel Distributors Corp