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Aprodine by Rebel Distributors Corp

Medically reviewed on August 10, 2018

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg, TRIPROLIDINE HYDROCHLORIDE 2.5mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-929

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 
pseudoephedrine hcl and tripolidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-929(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:21695-929-6060 TABLET, FILM COATED (TABLET) 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/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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