Pseudoephedrine Hydrochloride
- Dosage form
- TABLET
- Labeler
- CARDINAL HEALTH 110, LLC DBA LEADER
- Label updated
- 2022-05-12
- Retrieved
- 2026-09-07
- Active ingredients
- PSEUDOEPHEDRINE HYDROCHLORIDE
Label information
Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl, USP 120 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
Label information
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
Label information
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
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
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 |
|
| children under 12 years | do not use this product in children under 12 years of age |
Other information
- store at 59° to 77° F in a dry place. Protect from light
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive ingredients
castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide
Questions?
call 1-800-406-7984
Label information
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
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20 COATED CAPSULE
SHAPED TABLETS
[Image in the official label — see DailyMed source]
DailyMed Set ID: a2189d7d-9335-4e96-8f6d-95c583739ac0 · Version 2
NDC: 70000-0601