APRODINE- pseudoephedrine hcl and tripolidine tablet, film coated

Aprodine by

Drug Labeling and Warnings

Aprodine by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

APRODINE 
pseudoephedrine hcl and tripolidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-929(NDC:0904-0250)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;178
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-929-60	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/09/1993

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK