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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, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Ohm Laboratories Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
7
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
Pseudoephedrine Hydrochloride 240 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
13

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 20260106). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260106 HUMAN OTC DRUG · 20200811 HUMAN OTC DRUG · 20190529

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and over swallow one whole tablet with water every 24 hours do not exceed one tablet in 24 hours do not divide, crush, chew or dissolve the tablet the tablet does not completely dissolve and may be seen in the stool (this is normal) 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 had obstruction or narrowing of the bowel Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).

Stop Use

openFDA Drug Labeling

nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever you experience persistent abdominal pain or vomiting

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each tablet) Pseudoephedrine Hydrochloride USP 240 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
58602-884-27 58602-884 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK December 29, 2025
58602-884-58 58602-884 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-884-58) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK December 29, 2025
53943-204-10 53943-204 DISCOUNT DRUG MART 1 BLISTER PACK in 1 CARTON (53943-204-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 2, 2018
37808-007-69 37808-007 HEB 1 BLISTER PACK in 1 CARTON (37808-007-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 15, 2019
51660-492-21 51660-492 Ohm Laboratories Inc. 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-492-21) April 28, 2006
62011-0306-1 62011-0306 STRATEGIC SOURCING SERVICES LLC 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (62011-0306-1) February 20, 2017
0363-6611-10 0363-6611 WALGREEN CO. 1 BLISTER PACK in 1 CARTON (0363-6611-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK January 30, 2026
58602-884 58602-884 Aurohealth LLC — December 29, 2025
53943-204 53943-204 DISCOUNT DRUG MART — March 2, 2018
37808-007 37808-007 HEB — May 15, 2019
51660-492 51660-492 Ohm Laboratories Inc. — April 28, 2006
62011-0306 62011-0306 STRATEGIC SOURCING SERVICES LLC — February 20, 2017
0363-6611 0363-6611 WALGREEN CO. — January 30, 2026

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.