Drugplain

Nasal Decongestant 30 mg/1

Pseudoephedrine HCl · TABLET · Proficient Rx LP

10 Recalls on Record
Plain English

Pseudoephedrine HCl is an oral nasal decongestant tablet available over-the-counter that helps relieve nasal congestion from colds, allergies, and sinus pressure. It works by narrowing blood vessels in the nasal passages to reduce swelling and improve airflow.

Key Facts

Brand Name
Nasal Decongestant
Generic Name
Pseudoephedrine HCl
NDC Code (Product)
63187-344
Manufacturer
Proficient Rx LP
Strength
30 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
10/29/2012

Recall History

10 Recalls on Record
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
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class I04/15/2015

Reckitt Benckiser LLC

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II02/07/2014

Ohm Laboratories, Inc.

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

TerminatedVoluntary: 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

drug ineffective6,306 reports
pain5,957 reports
systemic lupus erythematosus5,536 reports
rheumatoid arthritis5,380 reports
pemphigus5,373 reports
abdominal discomfort5,325 reports
alopecia5,162 reports
fatigue5,022 reports
glossodynia4,958 reports
rash4,801 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 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor

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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 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.

Frequently Asked Questions

What is Nasal Decongestant used for?

Pseudoephedrine HCl is an oral nasal decongestant tablet available over-the-counter that helps relieve nasal congestion from colds, allergies, and sinus pressure. It works by narrowing blood vessels in the nasal passages to reduce swelling and improve airflow.

Is Nasal Decongestant a controlled substance?

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

What is the generic name for Nasal Decongestant?

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

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

The NDC (National Drug Code) for Nasal Decongestant 30 mg/1 is 63187-344, listed by Proficient Rx LP.