FDA.reportPublic FDA data

Mucus Relief DM

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2026-03-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:50:44

Label at a glance#

ProductMucus Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 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

do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

Storage and handling

each 20 mL contains: sodium 6 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

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

OTC - DO NOT USE SECTION

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 that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • dose as follows or as directed by a doctor
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 6 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER♥™

NDC 70000-0707-1

Maximum Strength

Mucus
Relief DM

Dextromethorphan HBr
Guaifenesin
Cough Suppressant | Expectorant

Berry
Flavored

For Ages 12 Years
and Over

Controls Cough

Relieves Chest
Congestion

Thins & Loosens
Mucus

COMPARE TO
MAXIMUM STRENGTH
MUCINEX® FAST-MAX®
DM MAX
active ingredients*

100% Money Back Guarantee

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse
www.stopmedicineabuse.org

*This product is not manufactured or distributed by RB
Health (US) LLC, owner of the registered trademark
Maximum Strength Mucinex® FAST-MAX® DM MAX.

50844        ORG042403145

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

©2024 CARDINAL HEALTH, LEADER, and LOGOs are
trademarks of Cardinal Health. All other marks are the
property of their respective owners.

100% Money Back Guarantee
Return to place of purchase if not satisfied.

Leader 44-031A
Leader 44-031A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN3
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY3
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3

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-130096295144369GTIN-13: 0096295144369
EAN-13: 0096295144369
GTIN-12: 096295144369
UPC-A: 096295144369
GTIN storage (14 digits): 00096295144369		leader-44-031a-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
70000-0707-1Mucus Relief DM177 mL in 1 BOTTLE, PLASTICSOLUTION1773

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0707-1ML - Milliliter70000-070725f8f52e-55b4-4a91-a13d-bedca766976f12025-06-13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-070770000-0707-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
ndc (package): 70000-0707-1
ndc (product): 70000-0707
ndc11 (package): 70000070701
spl id: ba51e344-1345-46bb-b98b-52cd5a72a518
spl set id: 4136e5f4-cc00-46d6-aa7f-ef56d087d7ec

Reported adverse events (FAERS/openFDA)#

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