Drugplain

Sudafed Sinus Congestion 12 Hour 120 mg/1

Pseudoephedrine Hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · A-S Medication Solutions

No Recall History
Plain English

Sudafed Sinus Congestion 12 Hour is an over-the-counter nasal decongestant that helps relieve sinus congestion and pressure caused by colds, allergies, or sinus infections. The extended-release tablet is designed to provide relief for up to 12 hours with each dose.

Key Facts

Brand Name
Sudafed Sinus Congestion 12 Hour
Generic Name
Pseudoephedrine Hydrochloride
NDC Code (Product)
50090-4629
Manufacturer
A-S Medication Solutions
Strength
120 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA075153
Marketing Start
06/17/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

systemic lupus erythematosus5,132 reports
pain5,079 reports
drug ineffective5,042 reports
pemphigus5,019 reports
rheumatoid arthritis5,005 reports
abdominal discomfort4,928 reports
alopecia4,848 reports
glossodynia4,668 reports
wound4,493 reports
swelling4,486 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 Sudafed Sinus Congestion 12 Hour used for?

Sudafed Sinus Congestion 12 Hour is an over-the-counter nasal decongestant that helps relieve sinus congestion and pressure caused by colds, allergies, or sinus infections. The extended-release tablet is designed to provide relief for up to 12 hours with each dose.

Is Sudafed Sinus Congestion 12 Hour a controlled substance?

Sudafed Sinus Congestion 12 Hour is not classified as a controlled substance by the DEA.

What is the generic name for Sudafed Sinus Congestion 12 Hour?

The generic name for Sudafed Sinus Congestion 12 Hour is Pseudoephedrine Hydrochloride. There are 11 other brand versions of Pseudoephedrine Hydrochloride.

What is the NDC code for Sudafed Sinus Congestion 12 Hour 120 mg/1?

The NDC (National Drug Code) for Sudafed Sinus Congestion 12 Hour 120 mg/1 is 50090-4629, listed by A-S Medication Solutions.

Product NDC

50090-4629

Package NDC

50090-4629-0

Other Pseudoephedrine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)