Drugplain

Leader Nasal Decongestant 30 mg/1

Pseudoephedrine HCl · TABLET, FILM COATED · Cardinal Health 110, LLC. dba Leader

1 Recall on Record
Plain English

Leader Nasal Decongestant is a tablet, film coated containing pseudoephedrine hcl at 30 mg/1, taken oral. Manufactured by Cardinal Health 110, LLC. dba Leader.

Key Facts

Brand Name
Leader Nasal Decongestant
Generic Name
Pseudoephedrine HCl
NDC Code (Product)
70000-0002
Manufacturer
Cardinal Health 110, LLC. dba Leader
Strength
30 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/20/2019

Recall History

1 Recall on Record
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain188 reports
drug ineffective160 reports
fatigue127 reports
abdominal discomfort125 reports
alopecia125 reports
rheumatoid arthritis116 reports
pemphigus115 reports
systemic lupus erythematosus115 reports
nausea86 reports
maternal exposure during pregnancy84 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage & Administration

Directions adults and children 12 years and over • take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 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

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 Nasal Decongestant used for?

Leader Nasal Decongestant contains Pseudoephedrine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Leader Nasal Decongestant a controlled substance?

Leader Nasal Decongestant is not classified as a controlled substance by the DEA.

What is the generic name for Leader Nasal Decongestant?

The generic name for Leader Nasal Decongestant is Pseudoephedrine HCl. There are 12 other brand versions of Pseudoephedrine HCl.

What is the NDC code for Leader Nasal Decongestant 30 mg/1?

The NDC (National Drug Code) for Leader Nasal Decongestant 30 mg/1 is 70000-0002, listed by Cardinal Health 110, LLC. dba Leader.