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Pseudoephedrine Hydrochloride

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Pseudoephedrine Hydrochloride
Generic name
Pseudoephedrine Hydrochloride
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Publix Super Markets Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
7
Packages
10
Data completeness
82% 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
17

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@FDANDC Directory
Application number
077442
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 28, 2005
Sponsor
SUN PHARM INDS LTD
Products on application
1
Submissions recorded
1
Products approved under application 077442.
Product Trade name Form Strength Ingredient Status TE Flags
077442-001 PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077442.
Type No. Action Status Date Review
Original application 1 Approved September 28, 2005 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241226). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241226 HUMAN OTC DRUG · 20190410

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, USP 120 mg

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
59779-204-21 59779-204 CVS Pharmacy 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (59779-204-21) April 28, 2006
59779-204-69 59779-204 CVS Pharmacy 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (59779-204-69) April 28, 2006
68016-204-69 68016-204 Chain Drug Consortium, LLC 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68016-204-69) April 28, 2006
63868-143-10 63868-143 Chain Drug Marketing Association Inc. 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63868-143-10) April 28, 2006
45802-107-52 45802-107 Padagis Israel Pharmaceuticals Ltd 10 BLISTER PACK in 1 CARTON (45802-107-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK May 24, 2014
56062-204-21 56062-204 Publix Super Markets Inc 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (56062-204-21) April 28, 2006
21130-204-21 21130-204 Safeway Inc. 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-21) April 28, 2006
21130-204-69 21130-204 Safeway Inc. 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-204-69) April 28, 2006
0363-0204-20 0363-0204 Walgreen Company 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20) January 16, 2019
0363-0204-69 0363-0204 Walgreen Company 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69) April 28, 2006
59779-204 59779-204 CVS Pharmacy — April 28, 2006
68016-204 68016-204 Chain Drug Consortium, LLC — April 28, 2006
63868-143 63868-143 Chain Drug Marketing Association Inc. — April 28, 2006
45802-107 45802-107 Padagis Israel Pharmaceuticals Ltd — May 24, 2014
56062-204 56062-204 Publix Super Markets Inc — April 28, 2006
21130-204 21130-204 Safeway Inc. — April 28, 2006
0363-0204 0363-0204 Walgreen Company — April 28, 2006

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.