FDA.reportPublic FDA data

MUCUS RELIEF DM

Manufacturer
Advanced Rx LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:29

Label at a glance#

ProductMUCUS RELIEF DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Dosage and administration

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours. Children under 12 years of age: Do not use

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

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
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

  • for children under 12 years of age
  • 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmcists before use if you are takingsedatives or tranquilizers

When using this productdo not use more than directed

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older:Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours.
  • Children under 12 years of age:Do not use

Other information

OTHER SAFETY INFORMATION

  • store between 20° - 25°C (68° - 77°F)
  • Keep in dry place and do not expose to heat
  • do not use if imprinted safety seal under the cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Hypromellose 5 & 15, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, PEG 400, PVP K30, Purified Water, Sodium Starch Glycolate, Stearic Acid Powder.

Questions?

OTC - QUESTIONS SECTION

call toll free  1-800-630-8895

Distributed by:

SPL UNCLASSIFIED SECTION

ADVANCED RX LLC

1942 NE 163ST North Miami Beach,

FL 33162 U.S.A

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-407-09

*Compare to Mucine ® DM active ingredients

Mucus Relief DM

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Cough Suppresant & Expectorant

90 Tablets

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex ® DM Tablets.

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN1
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD1
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY1

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
80513-407-09MUCUS RELIEF DM90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-407MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [ADVANCED RX LLC]1Current NDC, 1 package rows20250207_64620186-a45b-4c35-a3b9-a347348f93f7.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-40780513-407-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
HYPROMELLOSE 2910 (15 MPA.S)36SFW2JZ0WIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

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
MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBRAdvanced Rx LLC64620186-a45b-4c35-a3b9-a347348f93f72025-01-01WarningsExact identifier
ndc (package): 80513-407-09
ndc (product): 80513-407
ndc11 (package): 80513040709
spl id: 2d617549-ae71-6142-e063-6394a90accc7
spl set id: 64620186-a45b-4c35-a3b9-a347348f93f7

Reported adverse events (FAERS/openFDA)#

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