FDA.reportPublic FDA data

Mucus Relief DM

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:28:38

Label at a glance#

ProductMucus Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure16 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    o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants    o the intensity of coughing    o 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 400mg

Purpose

OTC - PURPOSE SECTION

Dextromethorphan HBr 20 mg ......................................... Cough suppressant
Guaifenesin 400mg ........................................................................ 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
   o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
   o the intensity of coughing
   o the impulse to cough to help you get to sleep

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 year 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 an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be sign of serious illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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: 

SPL UNCLASSIFIED SECTION

Store between 20ºC-25ºC (68ºF-77ºF).

  • Keep in a dry place and do not expose to heat 
  • do not use if imprinted safety seal under cap is broken or missing.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Reckitt Benckiser’s, owner of the registered trademark MUCINEX DM® Tablets.

SPL UNCLASSIFIED SECTION

Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0126 - Mucus Relief DM 200ct-Elysium 08.09.2023PL0126 - Mucus Relief DM 200ct-Elysium 08.09.2023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN2
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD2
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372090001640GTIN-13: 0372090001640
EAN-13: 0372090001640
GTIN-12: 372090001640
UPC-A: 372090001640
GTIN storage (14 digits): 00372090001640		PL0126 - Mucus Relief DM 200ct-Elysium 08.09.2023.jpg

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
72090-027-01Mucus Relief DM150 in 1 BOTTLETABLET1502

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-02772090-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
microcrystalline celluloseOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT

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 DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGPioneer Life Sciences, LLC3ce0f096-906e-47eb-8061-0ac1e9d8ea552025-12-26WarningsExact identifier
ndc (package): 72090-027-01
ndc (product): 72090-027
ndc11 (package): 72090002701
spl id: bb1fdbc8-40db-4b1e-bd9f-3d8fdfa6d4a3
spl set id: 3ce0f096-906e-47eb-8061-0ac1e9d8ea55

Reported adverse events (FAERS/openFDA)#

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