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 Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

APRODINE 
pseudoephedrine hcl and tripolidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-100(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
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
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;178
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-100-24	1 in 1 CARTON	09/04/2018
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(71205-100)