APRODINE- pseudoephedrine hcl and triprolidine hcl tablet, film coated 
Major Pharmaceuticals

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.

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Major 44-178

Active ingredients (in each tablet)

Pseudoephedrine HCl 60 mg
Triprolidine HCl 2.5 mg

Purpose

Nasal decongestant
Antihistamine

Uses

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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-0250-24

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            REV0719N17808

Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

Rev. 11/19      M-17
Re-order No. 700796

Major 44-178

Major 44-178

APRODINE 
pseudoephedrine hcl and triprolidine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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
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)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code 44;178
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-0250-241 in 1 CARTON01/09/1993
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0904-0250-591 in 1 CARTON01/09/1993
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/09/1993
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0904-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0904-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0904-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0904-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0904-0250)

Revised: 12/2020
Document Id: 31ade281-ef09-4b6a-a44b-c0725d97b7ee
Set id: 2f58a9c3-cf9a-4f2d-a8d1-929c127351ff
Version: 11
Effective Time: 20201208
 
Major Pharmaceuticals