Mucus Relief

Manufacturer: TopCo Associates, LLC
Effective date: 2021-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 23:59:19

Label at a glance#

ProductMucus Relief Immediate Release

Active ingredientGUAIFENESIN

Label structure10 sections

Dosage and administration

Adults and children12 years of age and older Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under12 years of age: do not use

Storage and handling

store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F) keep in a dry place and do not expose to heat

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-423-0139

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Use(s)

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus)and thin bronchial secretions to make
coughs more productive to rid the bronchial passageway of bothersome mucus

Warnings

WARNINGS SECTION

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have

persistent or chronic cough such as
occurs with smoking, asthma, chronic
bronchitis or emphysema
cough accompanied by excessive phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage
do not use for more than 7 days

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts for more than 7 days, recurs, or is
accompanied by fever, rash, or persistent
headache. These could be signs of a
serious condition.

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children12 years of age and older Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

do not use if imprinted safety seal under cap is broken or missing

Storage

STORAGE AND HANDLING SECTION

store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)

keep in a dry place and do not expose to heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Questions

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	7
359601	guaifenesin 400 MG Oral Tablet	SCD	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76162-004-01	Mucus ReliefImmediate Release	100 in 1 BOTTLE	TABLET	100	7
76162-004-81	Mucus ReliefImmediate Release	2 in 1 CARTON	TABLET	2	7
76162-004-81	Mucus ReliefImmediate Release	200 in 1 BOTTLE	TABLET	200	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-004	MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN 400MG) TABLET [TOPCO ASSOCIATES, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20231108_7d91c6ab-d161-42b9-b353-0aa8f59619f8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Mucus Relief Immediate Release
Guaifenesin 400mg
GUAIFENESIN
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
POVIDONE
MALTODEXTRIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76162-004	76162-004-81, 76162-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
POVIDONE	FZ989GH94E	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier ndc (package): 76162-004-81 ndc (package): 76162-004-01 ndc (product): 76162-004 ndc11 (package): 76162000481 ndc11 (package): 76162000401 spl id: bf64ce65-6978-4634-bd02-ab1389acf47d spl set id: 7d91c6ab-d161-42b9-b353-0aa8f59619f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.