Drugplain

Nasal Decongestant Maximum Strength 30 mg/1

Pseudoephedrine HCl · TABLET, FILM COATED · Strategic Sourcing Services LLC

3 Recalls on Record
Plain English

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

Key Facts

Brand Name
Nasal Decongestant Maximum Strength
Generic Name
Pseudoephedrine HCl
NDC Code (Product)
70677-1017
Manufacturer
Strategic Sourcing Services LLC
Strength
30 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
04/06/2023

Recall History

3 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

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

TerminatedVoluntary: Firm initiated
Class III10/11/2022

LNK International, Inc.

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

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

Side Effects Reported to FDA

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

pain150 reports
drug ineffective139 reports
abdominal discomfort118 reports
alopecia118 reports
pemphigus115 reports
rheumatoid arthritis115 reports
systemic lupus erythematosus115 reports
fatigue84 reports
maternal exposure during pregnancy79 reports
rash67 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 Nasal Decongestant Maximum Strength used for?

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

Is Nasal Decongestant Maximum Strength a controlled substance?

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

What is the generic name for Nasal Decongestant Maximum Strength?

The generic name for Nasal Decongestant Maximum Strength is Pseudoephedrine HCl. There are 11 other brand versions of Pseudoephedrine HCl.

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

The NDC (National Drug Code) for Nasal Decongestant Maximum Strength 30 mg/1 is 70677-1017, listed by Strategic Sourcing Services LLC.