APRODINE- pseudoephedrine hcl, triprolidine hcl tablet, film coated

Aprodine by

Drug Labeling and Warnings

Aprodine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. 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 (allergic rhinitis) or other upper respiratory allergies:
  • runny nose
    
  • itchy, watery eyes
    
  • nasal congestion
    
  • sneezing
    
  • itching of the nose or throat
    
• temporarily relieves these symptoms due to the common cold:
  • runny nose
    
  • sneezing
    
  • nasal congestion

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
  
• difficulty in urination due to enlargement of the prostate gland
  

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• do not exceed recommended dosage
  
• excitability may occur, especially in children
  
• use caution when driving a motor vehicle or operating machinery
  
• drowsiness may occur
  
• avoid alcoholic beverages
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  

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

• do not take more than directed
  
• 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
  

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number
  

Inactive ingredients

hypromellose, magnesium stearate, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

MAJOR®

NDC: 0904-7302-24

Maximum Strength

Aprodine™ Tablets
Pseudoephedrine HCl 60 mg
Triprolidine HCl 2.5 mg

60 mg/2.5 mg

Nasal Decongestant/Antihistamine

Relieves Nasal Congestion,
Sneezing, Runny Nose,
Itchy, Watery Eyes

Actual Size 

24 Tablets

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS 
ANY SIGNS OF TAMPERING

50844 ORG112328708

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Major 44-287A

INGREDIENTS AND APPEARANCE

APRODINE 
pseudoephedrine hcl, triprolidine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7302
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	287
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7302-24	1 in 1 CARTON	11/11/2022
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0904-7302-60	1 in 1 CARTON	11/11/2022
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/11/2022

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(0904-7302)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(0904-7302) , pack(0904-7302)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(0904-7302)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(0904-7302)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(0904-7302)