PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated 
Major Pharmaceuticals

----------

Pseudoephedrine hydrochloride

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl, USP 120 mg

Purpose

Nasal decongestant

Uses

Warnings

Do not useif 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dosage

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. (1-800-222-1222)

Directions

adults and children 12 years and over
  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 yearsdo not use this product in children under 12 years of age

Other information

Inactive ingredients

castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide

Questions?

call 1-800-406-7984

Distributed by:

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

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

MAJOR ®

NDC 0904-7409-15

Compare to the active 

ingredient of Sudafed ® Sinus

Congestion 12-Hour**

Maximum Strength 

Pseudoephedrine Hydrochloride

12 Hour Extended-Release Tablets, USP

120 mg

Long-Acting Nasal Decongestant

Relieves Sinus Pressure and Congestion

Non-Drowsy

10 Coated Tablets** 120 mg each

**Capsule-shaped Tablets

Actual Size

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7409
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7409-151 in 1 CARTON06/07/2024
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744206/07/2024
Labeler - Major Pharmaceuticals (191427277)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(0904-7409)

Revised: 6/2024
Document Id: 1b23c014-95b2-ac65-e063-6294a90a5d5d
Set id: 658b0fe8-d564-4f79-bbb2-939c518651b7
Version: 2
Effective Time: 20240618
 
Major Pharmaceuticals