Drugplain

12 Hour Nasal Decongestant 120 mg/1

Pseudoephedrine hydrochloride · TABLET, FILM COATED · CARDINAL HEALTH

2 Recalls on Record
Plain English

12 Hour Nasal Decongestant is a tablet, film coated containing pseudoephedrine hydrochloride at 120 mg/1, taken oral. Manufactured by CARDINAL HEALTH.

Key Facts

Brand Name
12 Hour Nasal Decongestant
Generic Name
Pseudoephedrine hydrochloride
NDC Code (Product)
70000-0656
Manufacturer
CARDINAL HEALTH
Strength
120 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA077442
Marketing Start
05/16/2024

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

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 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 12 Hour Nasal Decongestant used for?

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

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 70000-0656, listed by CARDINAL HEALTH.