PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet 
The Kroger Company

----------

Pseudoephedrine Hydrochloride

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl, USP 120 mg

Purpose

Nasal decongestant

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

  • 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, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton

COMPARE TO the active ingredient of
SUDAFED® 12 HOUR **See side panel

NDC 30142-967-20

Kroger®

OUR PHARMACIST RECOMMENDED

Maximum Strength

Sinus

Pseudoephedrine Hydrochloride 120 mg
12 Hour Extended-Release Tablets, USP

LONG ACTING
NASAL DECONGESTANT

NON-DROWSY

Relieves Sinus
Pressure + Congestion

actual
size

12
HOUR

20 COATED
CAPLETS*
120 mg EACH
*capsule-shaped tablets

PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton
PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-967
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code 204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-967-202 in 1 CARTON02/19/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744202/19/2021
Labeler - The Kroger Company (006999528)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(30142-967)

Revised: 4/2021
Document Id: 77ce98b8-4c34-41de-8d2b-45137f48a692
Set id: 00a8327b-41f0-4498-ad13-331256b539f9
Version: 2
Effective Time: 20210413
 
The Kroger Company