Guaifenesin and Pseudoephedrine Hydrochloride — Tablet, Extended Release

Overview

Brand name

Guaifenesin and Pseudoephedrine Hydrochloride

Generic name

Guaifenesin and Pseudoephedrine Hydrochloride

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

STRATEGIC SOURCING SERVICES LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

3

Packages

5

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
Guaifenesin	600 mg/1	359601	View
Pseudoephedrine Hydrochloride	60 mg/1	1305603	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Extended Release

Route of administration

Oral

Presentations

8

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
Decreased Respiratory Secretion Viscosity [PE]	PE	All 52 members
Expectorant [EPC]	EPC	All 48 members
Increased Respiratory Secretions [PE]	PE	All 48 members
alpha-Adrenergic Agonist [EPC]	EPC	All 85 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

212542

Application type

ANDA · Abbreviated New Drug Application

Approval date

April 28, 2020

Sponsor

SUN PHARM INDS INC

Products on application

2

Submissions recorded

1

Products approved under application 212542.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE		GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	Over-the-counter	—
212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE		GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 212542.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	April 28, 2020	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20220208). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20220208 HUMAN OTC DRUG · 20181027

Indications and Usage

openFDA Drug Labeling

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Purpose

openFDA Drug Labeling

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant

Dosage and Administration

openFDA Drug Labeling

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours children under 12 years of age: do not use

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 • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • do not use more than directed Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. 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 • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant

Adverse event reports

Source: openFDA FAERS

202,963

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: GUAIFENESIN. 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
41415-994-18	41415-994	PUBLIX SUPER MARKETS, INC	1 BLISTER PACK in 1 CARTON (41415-994-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	April 7, 2022
41415-994-36	41415-994	PUBLIX SUPER MARKETS, INC	2 BLISTER PACK in 1 CARTON (41415-994-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	April 7, 2022
62011-0475-1	62011-0475	STRATEGIC SOURCING SERVICES LLC	1 BLISTER PACK in 1 CARTON (62011-0475-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	December 10, 2017
0363-0077-18	0363-0077	WALGREEN COMPANY	1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	August 1, 2017
0363-0077-36	0363-0077	WALGREEN COMPANY	2 BLISTER PACK in 1 CARTON (0363-0077-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	August 1, 2017
41415-994	41415-994	PUBLIX SUPER MARKETS, INC	—	April 7, 2022
62011-0475	62011-0475	STRATEGIC SOURCING SERVICES LLC	—	November 15, 2017
0363-0077	0363-0077	WALGREEN COMPANY	—	August 1, 2017

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 · 10 sections on this page.