Sudafed Sinus Congestion 12 Hour — Tablet, Film Coated, Extended Release

Overview

Brand name

Sudafed Sinus Congestion 12 Hour

Generic name

Pseudoephedrine Hydrochloride

Dosage form

Tablet, Film Coated, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Kenvue Brands LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Pseudoephedrine Hydrochloride	120 mg/1	1305603	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated, Extended Release

Route of administration

Oral

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Adrenergic alpha-Agonists [MoA]	MoA	All 85 members
alpha-Adrenergic Agonist [EPC]	EPC	All 85 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

075153

Application type

ANDA · Abbreviated New Drug Application

Approval date

February 26, 1999

Sponsor

L PERRIGO CO

Products on application

1

Submissions recorded

11

Products approved under application 075153.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE		PSEUDOEPHEDRINE HYDROCHLORIDE	Over-the-counter	—	RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

No

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 075153.
Type	No.	Action	Status	Date	Review
Supplement	34	Labeling	Approved	May 24, 2011	—
Supplement	17	Labeling	Approved	April 20, 2005	—
Supplement	9	Manufacturing (CMC)	Approved	December 9, 2002	—
Supplement	6	Manufacturing (CMC)	Approved	May 7, 2002	—
Supplement	5	Manufacturing (CMC)	Approved	May 7, 2002	—
Supplement	8	Labeling	Approved	December 12, 2001	—
Supplement	7	Manufacturing (CMC)	Approved	October 22, 2001	—
Supplement	4	Manufacturing (CMC)	Approved	April 17, 2001	—
Supplement	3	Manufacturing (CMC)	Approved	April 17, 2001	—
Supplement	1	Manufacturing (CMC)	Approved	February 28, 2000	—
Original application	1		Approved	February 26, 1999	—

Review documents

0 · Original application · February 26, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250915). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250915 HUMAN OTC DRUG · 20241108

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

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).

Do Not Use

openFDA Drug Labeling

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

openFDA Drug Labeling

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Pseudoephedrine HCl 120 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-4629 NDC: 50090-4629-0 10 TABLET, FILM COATED, EXTENDED RELEASE in a BLISTER PACK / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS

36,595

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-4629-0	50090-4629	A-S Medication Solutions	1 BLISTER PACK in 1 CARTON (50090-4629-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	October 21, 2019
50580-242-01	50580-242	Kenvue Brands LLC	1 BLISTER PACK in 1 CARTON (50580-242-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	June 17, 2019
50580-242-02	50580-242	Kenvue Brands LLC	2 BLISTER PACK in 1 CARTON (50580-242-02) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	June 17, 2019
50580-242-03	50580-242	Kenvue Brands LLC	3 CARTON in 1 PACKAGE (50580-242-03) / 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	June 17, 2019
50090-4629	50090-4629	A-S Medication Solutions	—	June 17, 2019
50580-242	50580-242	Kenvue Brands LLC	—	June 17, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.