Topcare Mucus ER — Tablet, Multilayer, Extended Release

Overview

Brand name

Topcare Mucus ER

Generic name

guaifenesin

Dosage form

Tablet, Multilayer, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Topco Associates 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	1200 mg/1	359601	View
Guaifenesin	600 mg/1	359601	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Multilayer, 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
Decreased Respiratory Secretion Viscosity [PE]	PE	All 52 members
Expectorant [EPC]	EPC	All 48 members
Increased Respiratory Secretions [PE]	PE	All 48 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

078912

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 23, 2011

Sponsor

PERRIGO R AND D

Products on application

2

Submissions recorded

6

Products approved under application 078912.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
078912-001	GUAIFENESIN	TABLET, EXTENDED RELEASE		GUAIFENESIN	Over-the-counter	—
078912-002	GUAIFENESIN	TABLET, EXTENDED RELEASE		GUAIFENESIN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 078912.
Type	No.	Action	Status	Date	Review
Supplement	23	Manufacturing (CMC)	Approved	May 23, 2025	Unknown
Supplement	21	Manufacturing (CMC)	Approved	April 15, 2025	Unknown
Supplement	19	Labeling	Approved	January 13, 2025	Standard
Supplement	14	Labeling	Approved	January 13, 2025	Standard
Supplement	1	Manufacturing (CMC)	Approved	March 12, 2015	—
Original application	1		Approved	November 23, 2011	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250529). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250529

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

Purpose

openFDA Drug Labeling

Purpose Expectorant

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 of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. • children under 12 years of age: do not use

Warnings

openFDA Drug Labeling

Warnings Do not use • for children under 12 years of age Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with 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 • for children under 12 years of age

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • 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 • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg

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
76162-123-58	76162-123	Topco Associates LLC	1 BOTTLE in 1 CARTON (76162-123-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	September 29, 2022
76162-123-60	76162-123	Topco Associates LLC	1 BOTTLE in 1 CARTON (76162-123-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	November 4, 2024
76162-409-01	76162-409	Topco Associates LLC	4 BLISTER PACK in 1 CARTON (76162-409-01) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK	April 9, 2025
76162-409-74	76162-409	Topco Associates LLC	2 BLISTER PACK in 1 CARTON (76162-409-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK	March 26, 2025
76162-523-01	76162-523	Topco Associates LLC	2 BLISTER PACK in 1 CARTON (76162-523-01) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK	September 9, 2022
76162-123	76162-123	Topco Associates LLC	—	September 29, 2022
76162-409	76162-409	Topco Associates LLC	—	March 26, 2025
76162-523	76162-523	Topco Associates LLC	—	September 9, 2022

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.