FDA.reportPublic FDA data

IBU ® Tablets

Manufacturer
Bryant Ranch Prepack
Effective date
2014-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1000
Source
legacy-cache
Hydrated at
2026-08-02 01:35:59

Label at a glance#

ProductMUCOSA DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

:Each immediate-release tablet contains

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

OTC - PURPOSE SECTION

Expectorant – Cough Suppressant

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)

Helps thin bronchial secretions to make coughs more productive

Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

WARNINGS SECTION

WARNINGS:Do not use 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.

DOSAGE & ADMINISTRATION SECTION

:Directions: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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin/DM 400/20mg Tablet

Label
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4458-12021-08-17C16284748780-19855e2a2-42d8-60a7-e053-dbdaa90a05bdIBU ® Tablets
63629-4458-22021-08-17C16284748780-19855e2a2-42d8-60a7-e053-dbdaa90a05bdIBU ® Tablets
63629-4458-12019-11-27C16284748780-19855e2a2-42d8-60a7-e053-dbdaa90a05bdIBU ® Tablets
63629-4458-22019-11-27C16284748780-19855e2a2-42d8-60a7-e053-dbdaa90a05bdIBU ® Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-280-06EA - Each49483-280b93edcce-7cd8-4ba1-886f-a2dfc6db3b3c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1000
GUAIFENESINACTIVE INGREDIENT495W7451VQ1000
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1000
GUAIFENESINACTIVE MOIETY495W7451VQ1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301000
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1000
POVIDONESINACTIVE INGREDIENTFZ989GH94E1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1000

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63629-445863629-4458-1, 63629-4458-2
49483-280

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONESFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

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
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 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
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
ndc (product): 49483-280
b25bfa71-cfa4-480f-a3a8-b3b3000426f171b67078-e702-4203-9323-70d03f7cc0312021-08-17WarningsExact identifier
spl set id: 71b67078-e702-4203-9323-70d03f7cc031

Reported adverse events (FAERS/openFDA)#

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