FDA.reportPublic FDA data

MUCUS RELIEF

Manufacturer
Major Pharmaceuticals | TIME CAP LABORATORIES, INC
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:55:51

Label at a glance#

ProductMUCUS RELIEF
Active ingredientGUAIFENESIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT: Each immediate-release tablet contains – Guaifenesin 400 mg

OTC - PURPOSE SECTION

PURPOSE: Expectorant

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

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 SECTION

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 excessive phlegm (mucus)

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 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 under 12 years of age do not use.

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Generic Section

SPL UNCLASSIFIED SECTION

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Refer to package label for Distributor's NDC Number

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucus Relief

Guaifenesin 400 mg

30 Tablets

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6232-46EA - Each0904-6232ce833251-b0fa-4741-bf11-bee5bc9486ba12013-02-13
0904-6232-52EA - Each0904-6232648cd839-32ee-4924-90fd-d26c446099d712013-02-13
49483-272-06EA - Each49483-27258558786-c85e-40fc-96a2-3b3579028fcd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
GUAIFENESINACTIVE MOIETY495W7451VQ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

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
0904-62320904-6232-46, 0904-6232-52
49483-272

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, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
ndc (product): 49483-272
98e12c75-67a4-0483-e053-2a95a90a337aba8c698e-eeec-4067-96c4-b1f81b22a39b2019-12-04WarningsExact identifier
spl id: 98e12c75-67a4-0483-e053-2a95a90a337a
spl set id: ba8c698e-eeec-4067-96c4-b1f81b22a39b

Reported adverse events (FAERS/openFDA)#

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