Indications and uses
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure
Nasal Decongestant
- Manufacturer
- Cardinal Health | LNK International, Inc.
- Effective date
- 2021-03-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:49:29
Label at a glance#
ProductNasal Decongestant Maximum Strength
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age
Contacts and useful links#
Websitewww.myleader.com
www.myleader.com
www.myleader.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
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
- trouble urinating due to an enlarged prostate gland
When using this product
do not exceed recommended dose.
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 (1-800-222-1222) right away.
Directions
| adults and children 12 years and older | take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours |
| children ages 6 to 12 years | take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours |
| children under 6 years | do not use this product in children under 6 years of age |
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin
Questions or comments?
1-800-426-9391
Principal Display Panel
NDC 70000-0135-2
LEADER™
Maximum Strength
Nasal Decongestant
Pseudoephedrine HCl, 30 mg | Nasal Decongestant
Non-Drowsy
Nasal & Sinus Congestion
Sinus Pressure
96 TABLETS
ACTUAL SIZE
COMPARE TO SUDAFED®
MAXIMUM STRENGTH CONGESTION
active ingredient*
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
CARTON 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® Maximum Strength Congestion. 50844 ORG071211246
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
| All LEADER™ Brand Products Have A 100% Money Back Guarantee |
Return to place of purchase if not satisfied.
©2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0135-1 | EA - Each | 70000-0135 | 4517db34-c152-4bb6-b584-5fb84363aa1a | 1 | 2017-07-07 |
| 70000-0135-2 | EA - Each | 70000-0135 | a699f58b-28ba-4f18-9f01-eab8a4500278 | 1 | 2017-07-07 |
Products#
Every source-derived product name is available through these pages.
- Nasal Decongestant Maximum Strength
- Pseudoephedrine HCl
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
- TRIACETIN
- SILICON DIOXIDE
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0135 | 70000-0135-1, 70000-0135-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 46a9b2da-285f-48f7-a235-9d711e45dc0f | c2ad146c-f74e-486e-948e-c0a6b419f9ff | 2022-10-21 | Warnings | c2ad146c-f74e-486e-948e-c0a6b419f9ff |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.