PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet 
CARDINAL HEALTH 110, LLC DBA LEADER

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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?

call 1-800-406-7984

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

NDC 70000-0601-1

LEADER

Maximum Strength | Non-Drowsy

Pseudoephedrine

Pseudoephedrine HCl, 120 mg
Extended-Release Tablets, USP
Long-Acting Nasal Decongestant

12 Hour
Sinus Pressure + Congestion

COMPARE TO
SUDAFED® 12 HOUR
active ingredient

100% Money Back Guarantee

20 COATED CAPSULE
SHAPED TABLETS

Principal Display Panel - 120 mg Tablet Blister Pack Carton
PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0601
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CASTOR OIL (UNII: D5340Y2I9G)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code 204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0601-11 in 1 CARTON03/09/2022
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744203/09/2022
Labeler - CARDINAL HEALTH 110, LLC DBA LEADER (063997360)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories184769029MANUFACTURE(70000-0601)

Revised: 5/2022
Document Id: 604a27bc-af28-4609-a9a2-33c2c60e090a
Set id: a2189d7d-9335-4e96-8f6d-95c583739ac0
Version: 2
Effective Time: 20220512
 
CARDINAL HEALTH 110, LLC DBA LEADER