FDA.reportPublic FDA data

MUCUS RELIEF

Manufacturer
SPIRIT PHARMACEUTICALS LLC | ELYSIUM PHARMACEUTICALS LTD
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:53:23

Label at a glance#

ProductMUCUS RELIEF
Active ingredientGUAIFENESIN
Label structure11 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)

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

EXPECTORANT

MUCUS 

RELIEF

  • Guaifenesin 400 mg

Thins &

Loosens

Mucus,

Relieves Chest Congestion

Actual Size

PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN5
359601guaifenesin 400 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-0116-12025-01-30C16284748780-12cef2736-a8b7-d83d-e063-dadaa90ab31fASSURED™ EXPECTORANT MUCUS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0116-1MUCUS RELIEF1 in 1 CARTONTABLET15
68210-0116-1MUCUS RELIEF15 in 1 BOTTLETABLET155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0116MUCUS RELIEF (GUAIFENESIN) TABLET [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20230120_daa57e73-7ebb-4ca7-972f-10856abd0b67.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-011668210-0116-1

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
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
GUAIFENESIN495W7451VQACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f28eadfc-4cce-52f4-e053-2a95a90a928edaa57e73-7ebb-4ca7-972f-10856abd0b672023-01-18WarningsExact identifier
spl id: f28eadfc-4cce-52f4-e053-2a95a90a928e
spl set id: daa57e73-7ebb-4ca7-972f-10856abd0b67

Reported adverse events (FAERS/openFDA)#

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