Leader 12 Hour Sinus Nasal Decongestant 120 mg/1
Pseudoephedrine HCl · TABLET, FILM COATED, EXTENDED RELEASE · Cardinal Health 110, LLC. dba Leader
Leader 12 Hour Sinus Nasal Decongestant is a tablet, film coated, extended release containing pseudoephedrine hcl at 120 mg/1, taken oral. Manufactured by Cardinal Health 110, LLC. dba Leader.
Key Facts
- Brand Name
- Leader 12 Hour Sinus Nasal Decongestant
- Generic Name
- Pseudoephedrine HCl
- NDC Code (Product)
70000-0735- Manufacturer
- Cardinal Health 110, LLC. dba Leader
- Strength
- 120 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075153
- Marketing Start
- 08/07/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
Dosage & Administration
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 years do not use this product in children under 12 years of age
Warnings
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).
Frequently Asked Questions
What is Leader 12 Hour Sinus Nasal Decongestant used for?
Leader 12 Hour Sinus Nasal Decongestant contains Pseudoephedrine HCl. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Leader 12 Hour Sinus Nasal Decongestant a controlled substance?
Leader 12 Hour Sinus Nasal Decongestant is not classified as a controlled substance by the DEA.
What is the generic name for Leader 12 Hour Sinus Nasal Decongestant?
The generic name for Leader 12 Hour Sinus Nasal Decongestant is Pseudoephedrine HCl. There are 11 other brand versions of Pseudoephedrine HCl.
What is the NDC code for Leader 12 Hour Sinus Nasal Decongestant 120 mg/1?
The NDC (National Drug Code) for Leader 12 Hour Sinus Nasal Decongestant 120 mg/1 is 70000-0735, listed by Cardinal Health 110, LLC. dba Leader.
Other Pseudoephedrine Brands
See all →- pseudoephedrine hydrochloride30 mg/145802-432
- SUDOGEST NASAL DECONGESTANT30 mg/150090-4345
- Sinus and Nasal Decongestant30 mg/151316-121
- pseudoephedrine hydrochloride30 mg/185766-049
- Nasal Decongestant Maximum Strength30 mg/121130-112
- Sinus and Congestion Non-Drowsy30 mg/149035-780
- Nasal Decongestant30 mg/163187-344
- Nasal Decongestant30 mg/10536-3607
- Sinus Decongestion30 mg/130142-641
- nasal decongestant maximum strength non drowsy30 mg/141250-432
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)