Nasal Decongestant PE
Leader 44-453
0e804d71-1a61-4131-9b00-fde3ada7c7f8
HUMAN OTC DRUG LABEL
Aug 6, 2025
Cardinal Health 110, LLC. DBA Leader
DUNS: 063997360
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
LEADER™
NDC 70000-0126-1
Maximum Strength | Non-Drowsy
Nasal
** Decongestant PE**
Phenylephrine HCl, 10 mg | Nasal Decongestant
Sinus Pressure + Congestion
Pseudoephedrine-Free
18TABLETS
Actual size
COMPARE TO SUDAFED
PE® SINUS CONGESTION
active ingredient*
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
** OPENED OR IF BLISTER UNIT IS TORN, BROKEN**
** OR SHOWS ANY SIGNS OF TAMPERING**
*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Sudafed PE® Sinus
Congestion.
50844 REV0820A45323
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.
44-453
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Nasal decongestant
WARNINGS SECTION
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
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the 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 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: ask a doctor
STORAGE AND HANDLING SECTION
Other information
*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-426-9391