Drugplain

Pseudoephedrine Hydrochloride 120 mg/1

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

4 Recalls on Record
Plain English

Pseudoephedrine Hydrochloride is a tablet, film coated, extended release containing pseudoephedrine hydrochloride at 120 mg/1, taken oral. Manufactured by CVS Pharmacy.

Key Facts

Brand Name
Pseudoephedrine Hydrochloride
Generic Name
Pseudoephedrine Hydrochloride
NDC Code (Product)
59779-204
Manufacturer
CVS Pharmacy
Strength
120 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA077442
Marketing Start
04/28/2006

Recall History

4 Recalls on Record
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

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 Pseudoephedrine Hydrochloride used for?

Pseudoephedrine Hydrochloride contains Pseudoephedrine Hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Pseudoephedrine Hydrochloride a controlled substance?

Pseudoephedrine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Pseudoephedrine Hydrochloride?

The generic name for Pseudoephedrine Hydrochloride is Pseudoephedrine Hydrochloride. There are 10 other brand versions of Pseudoephedrine Hydrochloride.

What is the NDC code for Pseudoephedrine Hydrochloride 120 mg/1?

The NDC (National Drug Code) for Pseudoephedrine Hydrochloride 120 mg/1 is 59779-204, listed by CVS Pharmacy.