MUCUS RELIEF

Manufacturer: SPIRIT PHARMACEUTICALS LLC
Effective date: 2024-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:42:41

Label at a glance#

ProductMUCUS RELIEF

Active ingredientGUAIFENESIN

Label structure10 sections

Indications and uses

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

Dosage and administration

do not crush, chew, or break caplet take with a full glass of water adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 caplets in 24 hours. children under 12 years of age: do not use

Storage and handling

store between 20-25°C (68-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-333-9792

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

do not crush, chew, or break caplet
take with a full glass of water
adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 caplets in 24 hours.
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOUNDBODY ^TM

MUCUS

RELIEF

Guaifenesin 400 mg

Expectorant

Thins &

Loosens

Mucus,

Relieves Chest Congestion

60 Caplets

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	6
359601	guaifenesin 400 MG Oral Tablet	SCD	6

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	Strength	SPL version
68210-0611-6	MUCUS RELIEF	60 in 1 BOTTLE	TABLET	60		6
68210-0611-6	MUCUS RELIEF	1 in 1 CARTON	TABLET	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-0611	MUCUS RELIEF (GUAIFENESIN) TABLET [SPIRIT PHARMACEUTICALS LLC]	6	Legacy NDC, 2 package rows	20241215_0b0ce8a2-7a3a-49cf-8b47-247ddfd93805.zip

Products#

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

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

MUCUS RELIEF
GUAIFENESIN
SILICON DIOXIDE
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-0611	68210-0611-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML · Source PDF

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
292d51c8-dc41-35db-e063-6294a90a63be			0b0ce8a2-7a3a-49cf-8b47-247ddfd93805	2024-12-13	Warnings	Exact identifier spl id: 292d51c8-dc41-35db-e063-6294a90a63be spl set id: 0b0ce8a2-7a3a-49cf-8b47-247ddfd93805

Reported adverse events (FAERS/openFDA)#

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