Mucosa DM

Manufacturer
Magno-Humphries, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:58:11

Label at a glance#

ProductMucosa DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Indications and uses

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.

Dosage and administration

adults and children 12 years & older - take one 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

Label contents#

Full prescribing information#

MHL NDC 54257-277-01 immediate Acting

SPL UNCLASSIFIED SECTION

Mucosa DM

EXPECTORANT/COUGH SUPPRESSANT

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

50 TABLETS

  • Soothes Cough
  • Loosens Congestion

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20mg

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Dextromethorphan HBr 20mg.........Cough Suppressant Guaifenesin 400 mg.................................Expectorant

Uses

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

WARNINGS SECTION

​a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product. ​Do not use for children under 12. Do not use if you are now taking

​cougha ccompanied with excessive phlegm (mucus), persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. ​Ask a doctor before use if you have 

​ do not use for more than 7 days. ​When using this product do not exceed recommended dosage

​ cough lasts for more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache. These could be signs of a serious condition. ​Stop use and ask a doctor if

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years & older - take one 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

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 15° to 30°C (59° to 86°F) Keep in a dry place and do not expose to excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxxide, stearic acid.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

​Distributed by: Magno-Humphries, Inc., OR 97223 U.S.A. Visit our website: ​www.magno-humphries.com

SPL UNCLASSIFIED SECTION

​Tigard, OR 97223 U.S.A. ​Distributed by: Magno-Humphries, Inc.

Visit our website:

​www.magno-humphries.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN6
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD6
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-277-01Mucosa DM50 in 1 BOTTLETABLET506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-277MUCOSA DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET [MAGNO-HUMPHRIES, INC.]6Current NDC, Legacy NDC, 1 package rows20231030_3a5533fb-1c83-4b95-9cd2-9be663d3ff5f.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54257-27754257-277-01

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 · 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
Mucosa DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMagno-Humphries, Inc.3a5533fb-1c83-4b95-9cd2-9be663d3ff5f2023-10-27WarningsExact identifier
ndc (package): 54257-277-01
ndc (product): 54257-277
ndc11 (package): 54257027701
spl id: 08bf6b23-2a76-3732-e063-6294a90a2305
spl set id: 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f

Reported adverse events (FAERS/openFDA)#

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