Drugplain

12 Hour Nasal Decongestant 120 mg/1

Pseudoephedrine Hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · CVS Pharmacy

2 Recalls on Record
Plain English

This is an over-the-counter nasal decongestant tablet containing pseudoephedrine that helps relieve nasal congestion from colds, allergies, or sinus pressure with extended-release formulation designed to work for up to 12 hours. It works by narrowing blood vessels in the nasal passages to reduce swelling and improve airflow.

Key Facts

Brand Name
12 Hour Nasal Decongestant
Generic Name
Pseudoephedrine Hydrochloride
NDC Code (Product)
59779-703
Manufacturer
CVS Pharmacy
Strength
120 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA075153
Marketing Start
12/01/1999

Recall History

2 Recalls on Record
Class II12/28/2023

Seaway Pharma Inc.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

OngoingVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

systemic lupus erythematosus5,132 reports
pain5,117 reports
drug ineffective5,101 reports
pemphigus5,019 reports
rheumatoid arthritis5,007 reports
abdominal discomfort4,941 reports
alopecia4,861 reports
glossodynia4,670 reports
fatigue4,519 reports
wound4,493 reports

Frequently Asked Questions

What is 12 Hour Nasal Decongestant used for?

This is an over-the-counter nasal decongestant tablet containing pseudoephedrine that helps relieve nasal congestion from colds, allergies, or sinus pressure with extended-release formulation designed to work for up to 12 hours. It works by narrowing blood vessels in the nasal passages to reduce swelling and improve airflow.

Is 12 Hour Nasal Decongestant a controlled substance?

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

What is the generic name for 12 Hour Nasal Decongestant?

The generic name for 12 Hour Nasal Decongestant is Pseudoephedrine Hydrochloride. There are 10 other brand versions of Pseudoephedrine Hydrochloride.

What is the NDC code for 12 Hour Nasal Decongestant 120 mg/1?

The NDC (National Drug Code) for 12 Hour Nasal Decongestant 120 mg/1 is 59779-703, listed by CVS Pharmacy.