basic care mucus dm — Tablet, Extended Release

Overview

Brand name

basic care mucus dm

Generic name

dextromethorphan hydrobromide, guaifenesin

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Amazon.com Services LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

4

NDC product codes

2

Packages

3

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
Dextromethorphan Hydrobromide	30 mg/1	1094538	View
Dextromethorphan Hydrobromide	60 mg/1	1094538	View
Guaifenesin	1200 mg/1	359601	View
Guaifenesin	600 mg/1	359601	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Extended Release

Route of administration

Oral

Presentations

5

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
Sigma-1 Agonist [EPC]	EPC	All 44 members
Sigma-1 Receptor Agonists [MoA]	MoA	All 44 members
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]	EPC	All 44 members
Uncompetitive NMDA Receptor Antagonists [MoA]	MoA	All 44 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

207602

Application type

ANDA · Abbreviated New Drug Application

Approval date

March 5, 2018

Sponsor

PERRIGO R AND D

Products on application

2

Submissions recorded

1

Products approved under application 207602.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	TABLET, EXTENDED RELEASE		DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	Over-the-counter	—
207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	TABLET, EXTENDED RELEASE		DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 207602.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	March 5, 2018	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20210806). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20210806 HUMAN OTC DRUG · 20210713

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: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep

Purpose

openFDA Drug Labeling

Purposes Cough suppressant Expectorant

Dosage and Administration

openFDA Drug Labeling

Directions • do not crush, chew, or break 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: 1 or 2 tablets every 12 hours; not more than 4 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 • 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 • 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 • 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 • 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 • 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 ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg 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
72288-219-49	72288-219	Amazon.com Services LLC	1 BOTTLE in 1 CARTON (72288-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE	August 6, 2021
72288-812-55	72288-812	Amazon.com Services LLC	1 BOTTLE in 1 CARTON (72288-812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE	July 13, 2021
72288-812-66	72288-812	Amazon.com Services LLC	1 BOTTLE in 1 CARTON (72288-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE	July 9, 2021
72288-219	72288-219	Amazon.com Services LLC	—	August 6, 2021
72288-812	72288-812	Amazon.com Services LLC	—	July 9, 2021

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.