Drugplain

Leader Nasal Decongestant .5 mg/mL

Oxymetazoline Hydrochloride · SPRAY · Cardinal Health 110,Inc

1 Recall on Record
Plain English

Leader Nasal Decongestant is a spray containing oxymetazoline hydrochloride at .5 mg/mL, taken nasal. Manufactured by Cardinal Health 110,Inc.

Key Facts

Brand Name
Leader Nasal Decongestant
Generic Name
Oxymetazoline Hydrochloride
NDC Code (Product)
70000-0665
Manufacturer
Cardinal Health 110,Inc
Strength
.5 mg/mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
03/31/2024

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 Oxymetazoline Hydrochloride. It is a spray taken nasal. 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 Oxymetazoline Hydrochloride. There are 12 other brand versions of Oxymetazoline Hydrochloride.

What is the NDC code for Leader Nasal Decongestant .5 mg/mL?

The NDC (National Drug Code) for Leader Nasal Decongestant .5 mg/mL is 70000-0665, listed by Cardinal Health 110,Inc.