MUCOSA

Manufacturer
AvPAK
Effective date
2018-06-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:54:53

Label at a glance#

ProductMUCOSA
Active ingredientGUAIFENESIN
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


NDC 50268-383-15
Immediate-release GUAIFENESIN
400 mg
50 Tablets (5 x 10) Unit Dose

5026838315

NDC 50268-383-15
Immediate-release GUAIFENESIN
400 mg
50 Tablets (5 x 10) Unit Dose

5026838315

EXPECTORANT
●Relieves Chest Congestion
●Thins and Loosens Mucus

OTC - PURPOSE SECTION

DRUG FACTS:

ACTIVE INGREDIENT 
(Each immediate-release tablet) contains 
Guaifenesin 400 mg........Expectorant

USES
•Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS
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)

When using this product

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if

• 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.

WARNINGS SECTION

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

OTHER INFORMATION

• store at 25ºC (77º) excursions permitted between 15º - 30ºC (59º - 86ºF)
• keep in a dry place and do not expose to excessive heat

DOSAGE & ADMINISTRATION SECTION

INACTIVE INGREDIENTS

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

Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Mfg. Rev. 272R 0909         AV 03/15 (P)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 1
label 1
label 2
label 2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-383-11EA - Each50268-38396cf3d96-2046-46b9-9779-d8409b1f803d12015-11-12
50268-383-15EA - Each50268-383cbbba0ce-1283-40a0-ae23-f8a54c9e7f5712015-11-12
49483-272-06EA - Each49483-27258558786-c85e-40fc-96a2-3b3579028fcd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ2
GUAIFENESINACTIVE MOIETY495W7451VQ2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D2
PovidonesINACTIVE INGREDIENTFZ989GH94E2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A22
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2

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
50268-38350268-383-11, 50268-383-15
49483-272

Ingredients#

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

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

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
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
PovidonesPOVIDONEFZ989GH94ETABLET / 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
6e1104b3-924a-d3c2-e053-2991aa0ad3fe55647608-05de-4e85-e831-e6b654b9d8442018-06-07WarningsExact identifier
spl id: 6e1104b3-924a-d3c2-e053-2991aa0ad3fe
spl set id: 55647608-05de-4e85-e831-e6b654b9d844

Reported adverse events (FAERS/openFDA)#

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